drugs in the pipeline

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kugel

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Google alert for "antipsychotic" revealed the following report from an business publication, which I might have missed through the clinical literature:
http://www.pipelinereview.com/index...ophrenia-products-and-depot-formulations.html
in www.pipelinereview.com

"Eli Lilly presented new data for Zypadhera (olanzapine long-acting injection), [ that's way to close to "Zippidy-do-dah" for me] as it continues to seek US approval and enter the market that Johnson & Johnson (J&J) has pioneered through Risperdal Consta (risperidone long-acting injection).

Data from new oral atypical antipsychotics were also presented. Vanda followed up the recent surprise approval of oral Fanapt (iloperidone) by presenting two posters detailing comparative data. Dainippon Sumitomo, meanwhile, provided delegates the first chance to see Phase III data for lurasidone."

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There has been some speculation that a non-swallowed form of Olanzapine would cause less weight gain vs the oral form since one of its theorized effects is directly on receptors in the GI tract.

http://www.ncbi.nlm.nih.gov/pubmed/18219624?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=2&log$=relatedarticles&logdbfrom=pubmed

If this is indeed true, and I have seen animal studies where similar results happened, then one could expect that an Olanzapine depot could do the same.

Its pretty interesting because I've had the idea in the back of my mind to do a human study replicating the animal studies with Olanzapine & weight gain, but never had the time to do it. Looks someone beat me to it. Just goes to show what happens when you get lazy on a good idea.

Some others--using antioxidants to fight agranulocytosis caused by Clozapine
-use of sunglasses to reduce mania
-melatonin therapy to treat bipolar (some treatment approaches involve stabilizing circadian rhythms)
-combination Omega 3 fatty acids, S-adenosylmethionine & other OTCs in treating depression in combination with an SSRI, is there an added benefit?
-the PACT team that I used to work with noticed a particular set of patients on Risperdal Consta seemed to become treatment resistant to it after X amount of months on it. They were never able to quantify it in a controlled manner. Someone could do a study to further investigate this.

Go ahead, someone take the idea before I jump on it.
If you want to see plenty of cool new possible meds, Acadia Pharm is a company specifically geared towards doing psychiatry med research. Here's their meds in the pipeline.

http://www.acadia-pharm.com/pipeline/
 
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Today, the FDA approved Invega Sustenna, the long-acting injectable form of Invega (which is the active metabolite of risperidone).

http://health.usnews.com/articles/h...ained-release-antipsychotic-approved-for.html

Janssen tried long and hard to get an injectable form of Risperdal (Consta) to work for a month at a time, and finally had to give up. It will be interesting to see if Invega Sustenna really works for a month at a time, or is this really just a ploy to get docs/pts using Invega instead of Risperdal Consta before the patent clock runs out on that, too.

IMHO, the only thing Invega treats better than risperidone does, is an expiring patent. Esp. since the emergence of a second generic manufacturer for risperidone has significantly reduced the cost of risperidone.
 
Not really in the pipeline, but has anyone used Fanapt yet?
 
Today, the FDA approved Invega Sustenna, the long-acting injectable form of Invega (which is the active metabolite of risperidone).

http://health.usnews.com/articles/h...ained-release-antipsychotic-approved-for.html

Janssen tried long and hard to get an injectable form of Risperdal (Consta) to work for a month at a time, and finally had to give up. It will be interesting to see if Invega Sustenna really works for a month at a time, or is this really just a ploy to get docs/pts using Invega instead of Risperdal Consta before the patent clock runs out on that, too.
IMHO, the only thing Invega treats better than risperidone does, is an expiring patent. Esp. since the emergence of a second generic manufacturer for risperidone has significantly reduced the cost of risperidone.


I hope to retire as an "Invega virgin". The same goes for Pristiq.
 
Pristiq is not in the formula in our hospital and to be honest, I dont think I care. Effexor and Cymbalta pretty much got it covered. Now if it went through the kidneys, I would have been more interested.

Another dopamine agonst/antagonist wont make a difference and I will not need to prescribe it.

The 1 month shot would be worth it however. The rate of non-compliance is heavy. I hope it works better than risperdal cause Risperdal Consta is useless somewhat.
 
gaba-ergic antipsychotic sounds interesting.

have found many schizophrenic patients that seem to do better with scheduled low-dose long-acting benzos. Not unsurprising given recent literature. But still very cool.
 
IMHO, the only thing Invega treats better than risperidone does, is an expiring patent.

I strangely had a patient who had galactorrhea on Invega, but not on Risperdal (and I didn't put her on the Invega).

The only way I can see myself giving Invega is I have a patient who gets intolerable side effects from Risperdal, but hardly anything else would work. I haven't had a patient who fits that category.

If anything the med I'm really hating right now is Seroquel. Hey, I know every med has their place. There should be no favorite or hated meds. I personally actually favor Seroquel only if the person is ultra sensitive to the D2 blockage induced EPS (which is rare--I had a guy who got severe EPS from just 1 mg of Risperdal--all antipsychotics except Seroquel that were tried gave him very bad EPS--I'm talking to the point where he had to go to the ER because his muscles tensed up so much he was in extreme pain). I just took over an outpatient gig for moonlighting and the idiot attending 2 doctors before me put everyone on Xanax, Seroquel and Neurontin, no matter what their diagnosis was. So many of my new patients keep telling me they hate Seroquel, but didn't know they had any other options because they were dependent on what the doctor recommended to them. The guy before me was only there a few months, so he couldn't do much to fix the problem.

As for Neurontin, I don't know why the heck this guy put them on it. He didn't document why he did, and there's no controlled studies that I know of showing it has a mental health benefit except in reducing alcohol relapse.

Actually heck, I don't know what the heck he was doing with 3/4 of the patients. Person has Panic DO, and this guy puts the poor lady on Welbutrin, Neurontin, Xanax, and Seroquel. She was getting dependent on the Xanax by the time I started with her. I am tapering her off the Xanax and Neurontin, put her on an SSRI--and she says for the first time in years her panic attacks have gone down (from everyday to once a week), and stopped the Seroquel.

Sorry for the rant
 
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FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

7/30/2009 3:08:00 PM

KENILWORTH, N.J., July 30 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted unanimously in favor of SAPHRIS(R) (asenapine) sublingual tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of use in acute treatment of schizophrenia in adults. If approved by FDA, SAPHRIS would be the first psychotropic drug to be approved initially for both of these indications.
"We are very pleased with the outcome of today's advisory committee meeting and appreciate the panel's careful consideration of the efficacy and safety data for SAPHRIS," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "In clinical studies, SAPHRIS has demonstrated efficacy combined with an attractive metabolic safety profile. SAPHRIS has the potential to address a significant unmet need for patients with schizophrenia and bipolar I disorder, including patients starting treatment and those who need alternative treatment options when switching or re-initiating therapy. We will continue to work with FDA to bring SAPHRIS to the U.S. market as soon as possible so that patients can benefit from this new medication."
While the FDA is not bound by the committee's recommendations, the agency carefully considers them before making a final decision on approval. After reviewing the SAPHRIS data, the committee voted in favor of SAPHRIS as effective (by counts of 12/0/0 and 10/2/0, yes/no/abstain) and safe (12/0/0 and 10/0/2) for the bipolar I disorder and schizophrenia indications, respectively. In addition, the committee voted on the overall balance of safety and efficacy by counts of 12/0/0 and 9/1/2 for the bipolar I disorder and schizophrenia indications, respectively.
The New Drug Application (NDA) for SAPHRIS includes efficacy data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials, and is supported by safety data in 4,500 patients, with some treated for more than two years.
In Europe, a Marketing Authorization Application (MAA) for asenapine, under the brand name SYCREST(R), is currently under review by the European Medicines Agency (EMEA) for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.
Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.
 
FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

7/30/2009 3:08:00 PM

KENILWORTH, N.J., July 30 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted unanimously in favor of SAPHRIS(R) (asenapine) sublingual tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of use in acute treatment of schizophrenia in adults. If approved by FDA, SAPHRIS would be the first psychotropic drug to be approved initially for both of these indications.
"We are very pleased with the outcome of today's advisory committee meeting and appreciate the panel's careful consideration of the efficacy and safety data for SAPHRIS," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "In clinical studies, SAPHRIS has demonstrated efficacy combined with an attractive metabolic safety profile. SAPHRIS has the potential to address a significant unmet need for patients with schizophrenia and bipolar I disorder, including patients starting treatment and those who need alternative treatment options when switching or re-initiating therapy. We will continue to work with FDA to bring SAPHRIS to the U.S. market as soon as possible so that patients can benefit from this new medication."
While the FDA is not bound by the committee's recommendations, the agency carefully considers them before making a final decision on approval. After reviewing the SAPHRIS data, the committee voted in favor of SAPHRIS as effective (by counts of 12/0/0 and 10/2/0, yes/no/abstain) and safe (12/0/0 and 10/0/2) for the bipolar I disorder and schizophrenia indications, respectively. In addition, the committee voted on the overall balance of safety and efficacy by counts of 12/0/0 and 9/1/2 for the bipolar I disorder and schizophrenia indications, respectively.
The New Drug Application (NDA) for SAPHRIS includes efficacy data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials, and is supported by safety data in 4,500 patients, with some treated for more than two years.
In Europe, a Marketing Authorization Application (MAA) for asenapine, under the brand name SYCREST(R), is currently under review by the European Medicines Agency (EMEA) for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.
Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.

Yet another atypical antipsychotic that mass blocks all receptors and hopes for the best. This is getting old.
 
It'd be great if any new antispsychotic could be put under CATIE level study methods to see how they rack up against the other antipsychotics in the CATIE trial.
 
There are always new drugs in trial and coming to the market which are touted as the holy grail by the drug companies. I take the "wait and see" approach.... just like someone mentioned above...i'm still a pristiq invega virgin..
 
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There are always new drugs in trial and coming to the market which are touted as the holy grail by the drug companies. I take the "wait and see" approach.... just like someone mentioned above...i'm still a pristiq invega virgin..

I don't forsee myself prescribing pristiq until some indication not filled by cymbalta or effexor is established.

Invega however, I am surprised how many people are not using it. It's the only atypical I dont need to adjust for liver failure (which is common where I am Alcohol/Hep B/Hep C/Overdose of Tylenol).
 
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Invega however, I am surprised how many people are not using it. It's the only atypical I dont need to adjust for liver failure (which is common where I am Alcohol/Hep B/Hep C/Overdose of Tylenol).

I will admit that paliperidone does not require adjustment in regards to overt liver failure. But the dose may well require adjustment over time anyway for other reasons, like varying symptom severity due to changing CNS compromise from the liver failure.

Yes, there is a recommendation in the PDR for adjustment of dose in liver impairment, "the mean free fraction of risperidone in plasma was increased by about 35%". This would mean that a 6 mg/day dose is equivalent to 8.1 mg/day. The text does not say how serious was the liver impairment in the test subjects. Was it "mild elevation of liver enzymes" or ICU pts awaiting transplant?

It also says, "the pharmacokinetics of risperidone in subjects with liver disease were comparable to those in young healthy subjects...."
It seems the need for dosage adjustment was not due to reduction in metabolic capacity (P450 capacity), but due to reduction in plasma protein - thus reduced protein binding capacity, "because of the diminished concentration of both albumin and α1-acid glycoprotein."

I take that to mean that there would be no dosage adjustment necessary until there is a detectable drop in plasma protein levels - - which is almost never the case in the average outpt with hx of Alcohol/Hep B/Hep C. And my experience has been that such pts do not require signif. different dosing than pt's w/o such history. But adjusting the dose is a normal part of the practice of treating any patient who needs an antipsychotic, so being a bit more conservative with outpatients who have a history of potential liver problems shouldn't cause any serious difficulties. These are all things any psychiatrist would be thinking about while titrating any antipsychotic to effect vs side-effects.

Risperidone costs my county $0.65 for 3 mg, $1.30 for 6 mg.
Invega costs my county $10.13 for 3mg, $15.21 for 9mg.

If I spend 1000% more than I have to (esp for a "theoretical" benefit), we cut therapists, case managers, housing assistance, transportation, etc., etc. We've already closed clinics, closed every clinic every Friday, cut back hours on Mon-Thurs, and cut other services. And all our clinics now refuse to see anyone who does not have Medicaid or Medicare. Those with no funding source are simply NOT seen anywhere outside the hospital. And there simply is no other outpt resource for the indigent in our county. None.
I'm not kidding. If a new pt goes into one of our MH clinics without Medicaid or Medicare, (s)he will NOT see a doctor (even in a true psychiatric emergency) and will be told not to come back. If there is any SI or serious psychotic symptoms, the police/EMS will be called to whisk the pt away to the hospital - even if that might well have been avoided by seeing an MD briefly just one time.

Even when the money for prescriptions comes out of someone else's budget (private pt's in a private practice, w/ private insur and Rx coverage), it's coming from somewhere and the pot available for treating patients somewhere in the system gets smaller or the premiums on everyone else get larger.

I cannot pretend to treat patients in a vacuum.
 
...

Risperidone costs my county $0.65 for 3 mg, $1.30 for 6 mg.
Invega costs my county $10.13 for 3mg, $15.21 for 9mg.

If I spend 1000% more than I have to (esp for a "theoretical" benefit), we cut therapists, case managers, housing assistance, transportation, etc., etc. We've already closed clinics, closed every clinic every Friday, cut back hours on Mon-Thurs, and cut other services. ...

Even when the money for prescriptions comes out of someone else's budget (private pt's in a private practice, w/ private insur and Rx coverage), it's coming from somewhere and the pot available for treating patients somewhere in the system gets smaller or the premiums on everyone else get larger.

I cannot pretend to treat patients in a vacuum.

:thumbup::bow:
 
I will admit that paliperidone does not require adjustment in regards to overt liver failure. But the dose may well require adjustment over time anyway for other reasons, like varying symptom severity due to changing CNS compromise from the liver failure.

Yes, there is a recommendation in the PDR for adjustment of dose in liver impairment, "the mean free fraction of risperidone in plasma was increased by about 35%". This would mean that a 6 mg/day dose is equivalent to 8.1 mg/day. The text does not say how serious was the liver impairment in the test subjects. Was it "mild elevation of liver enzymes" or ICU pts awaiting transplant?

It also says, "the pharmacokinetics of risperidone in subjects with liver disease were comparable to those in young healthy subjects...."
It seems the need for dosage adjustment was not due to reduction in metabolic capacity (P450 capacity), but due to reduction in plasma protein - thus reduced protein binding capacity, "because of the diminished concentration of both albumin and α1-acid glycoprotein."

I take that to mean that there would be no dosage adjustment necessary until there is a detectable drop in plasma protein levels - - which is almost never the case in the average outpt with hx of Alcohol/Hep B/Hep C. And my experience has been that such pts do not require signif. different dosing than pt's w/o such history. But adjusting the dose is a normal part of the practice of treating any patient who needs an antipsychotic, so being a bit more conservative with outpatients who have a history of potential liver problems shouldn't cause any serious difficulties. These are all things any psychiatrist would be thinking about while titrating any antipsychotic to effect vs side-effects.

Risperidone costs my county $0.65 for 3 mg, $1.30 for 6 mg.
Invega costs my county $10.13 for 3mg, $15.21 for 9mg.

If I spend 1000% more than I have to (esp for a "theoretical" benefit), we cut therapists, case managers, housing assistance, transportation, etc., etc. We've already closed clinics, closed every clinic every Friday, cut back hours on Mon-Thurs, and cut other services. And all our clinics now refuse to see anyone who does not have Medicaid or Medicare. Those with no funding source are simply NOT seen anywhere outside the hospital. And there simply is no other outpt resource for the indigent in our county. None.
I'm not kidding. If a new pt goes into one of our MH clinics without Medicaid or Medicare, (s)he will NOT see a doctor (even in a true psychiatric emergency) and will be told not to come back. If there is any SI or serious psychotic symptoms, the police/EMS will be called to whisk the pt away to the hospital - even if that might well have been avoided by seeing an MD briefly just one time.

Even when the money for prescriptions comes out of someone else's budget (private pt's in a private practice, w/ private insur and Rx coverage), it's coming from somewhere and the pot available for treating patients somewhere in the system gets smaller or the premiums on everyone else get larger.

I cannot pretend to treat patients in a vacuum.

I am calling out the euphoric style of saying "invega virgin" when clearly the drug has a different use compared to the current atypicals. I'll agree with you that I and everyone should rarely use it (infact we rarely do over here for the exact reasons you mentioned) but to be proud of being "Invega virgin" is way different than to be proud of being "Pristiq virgin". It tells me that you will never think of use over price when use is 100% indicated and necessary.

PS: I'm a pristiq virgin myself and i doubt that will change soon.
 
Invega however, I am surprised how many people are not using it. It's the only atypical I dont need to adjust for liver failure

There are sometimes a need for the more expensive meds, but this is extremely rare. I see pretty much no need to put someone on Lexapro when Citalopram does the job about 99% of the time (edit-that Lexapro would've done). I would perhaps consider Lexapro if someone had liver problems & were on multiple medications, but even in those cases I have not seen any problems with Citalopram.

That being said, I have seen almost no doctor were I trained (and that's where you are training Faebinder) except Dr. Z ever factor in the cost of meds in the decision to prescribe. There were several patients who were noncompliant on Lexapro becuase they couldn't afford it, then the attending would write them a new prescription for........Lexapro.

I don't know if you guys are still giving out Citalopram a lot. I, along with the social workers helped to start that trend. They pointed out the $4 generics (which back then were brand new), and I would discuss that it should be used as a first line instead of the other more expensive medications, and why. None of the attendings were doing that.

As for other meds..
Augmentation with Abilify...Why? There's Buspirone and lithium augmentation--both cost $4 a month. Unless someone can show me that Abilify augmentation would be superior (and for that matter, pretty much any atypical has some data in antidepressant augmentation), why go for that? The only thing I can think of is if the person has MDD w/ psychotic features because at least they're getting some antipsychotic benefit. Abilify's raked in the profits bigtime with their new antidepressant augmentation advertisement campaign.

Carbamazepine--only $4 a month. Almost no one uses it.

Loxitane--will cost the system about $200-500 a month for this typical antipsychotic, which now has data showing it truly may really be an atypical. Its chemically very similar to Zyprexa, and I've noticed it works in several patients where Zyprexa was the only atypical (minus Clozaril) that worked for them. Zyprexa? About $700 a month.

Haldol--if it works and without side effects why not? Yes we need to be aware of the possible EPS, but I've seen several take this med without much if any EPS. Its depot form is very cheap compared to Risperdal Consta, and doesn't have to be given every 2 weeks.
 
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...
I don't know if you guys are still giving out Citalopram a lot. I, along with the social workers helped to start that trend. They pointed out the $4 generics (which back then were brand new), and I would discuss that it should be used as a first line instead of the other more expensive medications, and why. None of the attendings were doing that.
....

And don't forget fluoxetine! I'll usually use it if the pt appears to need a bit more activation, citalopram if they need to mellow out a bit more. The other great thing about fluoxetine is, for the homeless, chemically dependent and marginally compliant, if they miss a dose that long half-life keeps them pretty much at steady state plasma levels.
 
The other great thing about fluoxetine is, for the homeless, chemically dependent and marginally compliant, if they miss a dose that long half-life keeps them pretty much at steady state plasma levels.

Agree. If you got someone who occasionally misses a dose, this meds not a bad choice since its half life is a few days.

Welbutrin (the regular form, not the SR or XL versions) are now available as a $4 generic too.

I'm currently in a very "anyone who doesn't prescribe right is an idiot" mood for the past few weeks. I've taken over an outpatient gig for moonlighting where the doctor before me didn't seem to know what he was doing with his meds--multiple antipsychotics without any good reasoning, Adderall for anyone who said they were ADHD without proper testing, and if they had weight gain--he kept them on the meds that caused weight gain without trying something more metabolically neutral--so they were put on Topamax, Ranitidine and Welbutrin as well. Then he put them on Neurontin, Xanax or ativan for whatever reason (they don't have an anxiety disorder)

Here's a typical medication regimen that this guy put them on-the person had depression.

Paxil 40mg Qdaily
Seroquel 300mg QHS
Ranitidine (forgot the dosage)
Welbutrin 75mg
Ativan 2 mg TID
Neurontin 300mg QTID
Topamax (forgot the dosage)
Trazadone 300mg QHS

Just in court the other day, I had to give the prognosis of a patient that another doctor was treating--Bipolar with Topamax. I had to say to the judge that I couldn't give a prognosis because the person was being treated with a medication that has very little data on its efficacy. Hey, I wasn't trying to get the other doctor in trouble, but I'm not going to fudge the truth under oath. I spent 2 hrs trying to contact this doctor--who was on duty was not on the hospital grounds, and she never called me back.
 
I don't know if you guys are still giving out Citalopram a lot. I, along with the social workers helped to start that trend. They pointed out the $4 generics (which back then were brand new), and I would discuss that it should be used as a first line instead of the other more expensive medications, and why. None of the attendings were doing that.

We still all do, to the point that Dr. B accused me of having stocks in Celexa. :laugh:
 
Dr. B accused me of having stocks in Celexa

I hope he was being somewhat sarcastic because when I introduced the "novel" idea of factoring the costs of meds to the residents (and he was the assistant program director at the time) it seemed to fly through one ear & out the other. I wanted to get his approval, and I informed him several times, as well as the social workers also telling him--but the same thing kept happening with him...."Doctor, I can't afford Lexapro, that's why I stopped the medication"-------2 minutes later, prescription for Lexapro is written again.

After about 2 months of waiting for him to actually respond, I decided to just go ahead with my idea, and if he didn't approve, well he had 2 months, and just sat there. Rome may have not been built in a day, but it was built faster than a snail's pace.

Celexa is off patent. There is no one company that makes it where you can buy stocks.

Though I know you know these things.

Lexapro's sales at the hospital plummeted after I introduced the idea of using Citalopram, & if there was a problem with Citalopram to add Buspirone augmentation (that too is only $4/month). It was to the point where they started bringing in the Lexapro rep to the hospital, and offering us dinners they hadn't offered before.

That only signalled to me that we were on the right track. My intent was to put a dent in sales of a medication that was more expensive and not necessarily needed as much as it was given out. We also had a lot less people coming back to inpatient complaining they couldn't afford meds.
 
I agree with many of these thoughtful comments. Despite many years in clinical research, there are only three medications that have been released during my career that have changed the way I practice--Fluoxetine, Clozapine and Buprenorphine. A lot of the other drugs are me-too compounds, patent extenders and ways for drug companies to make some dough.

This is not to say that SNRIs are not a good addition just that we could do that with an SSRI and a tricyclic before but the SNRIs have better side effect profiles.
 
I am calling out the euphoric style of saying "invega virgin" when clearly the drug has a different use compared to the current atypicals.

I'm a little confused. What do you mean, "clearly the drug has a different use compared to the current atypicals?"
Not looking to pick a fight (and I'm not an Invega or Pristiq "virgin." That was someone else). Just wanting to understand what you meant.
 
I'm a little confused. What do you mean, "clearly the drug has a different use compared to the current atypicals?"
Not looking to pick a fight (and I'm not an Invega or Pristiq "virgin." That was someone else). Just wanting to understand what you meant.

Invega, goes through kidneys with no break down in the liver... clearly can be used in situations where all the other atypicals are contraindicated. Especially true on consults on the medical floor with elevated liver functions. You might not care about this on the inpatient units, but on the medical floor consults the game is different. So for a bipolar whom i need an adjunct APD or for someone with schizophrenia, and the medical team doesnt want the liver to be affected by the APD then Invega becomes useful. Likewise with nursing home patient with liver failure/elevated enzymes who needs an APD to stop him from beating up the staff. To completely ignore that tells me that you are letting the lack of $$ dictate your prescribing style over what's good for the patient. Can you use other atypicals, sure but you know which one would be better used in that situation.

On the other hand, Pristiq is pretty much like other SNRIs, going out the same route and indicated for the same symptoms. So being a pristiq virgin is okay and good for the overall.
 
To completely ignore that tells me that you are letting the lack of $$ dictate your prescribing style over what's good for the patient

Agree. Someone with severely compromised health--well the meds do affect the organs on some level. That of course has to be taken into consideration.

$$ is a factor, but the quality of care is more important. Of course more expensive meds do not always mean better treatment. I think there is a place for Invega, Pristiq, Lexapro and other similar meds. I also believe that the cheaper alternatives (Risperdal, Effexor, Citalopram) are going to be the better choice in over 90% of cases. Like I mentioned--I'd of course consider Lexapro for someone who has liver problems over Citalopram.

IMHO there never should be a "favorite" medication. Each has their place. I remember some residents mentioning "oh Risperdal is my favorite medication", putting in a lot of personal feelings, and not based on evidenced based practice. I'm not judging against residents because in the early stages of learning about these meds, it may actually be helpful to add some personal emotion to these things, but I'd also advocate to get past that initial phase by 2nd year.

However I think the bigger problem is not doctors who do not factor this is, but the doctors who pretty much just give one main medication to all patients because of a pharm dinner--which is (at least from what I've seen) a bigger problem than a doctor who's giving the cheapest meds out to all. I've never seen a doctor have the problem of simply giving out the cheapest meds because that does not reward the doctor, and several forces such as pharm reps prevent this. If anything, in general-- I've noticed that doctors that are aware of the cheaper meds are taking more factors into their decision making process.
 
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Invega, goes through kidneys with no break down in the liver... clearly can be used in situations where all the other atypicals are contraindicated. Especially true on consults on the medical floor with elevated liver functions.

AGREED. Invega could be helpful in that situation. In cases of severe impairment or liver failure, I could certainly be persuaded. However, the switch to Invega is, in many cases, as dangerous to the patient (psychiatrically) as the hepatic metabolism is (medically). But it has its place. Just the fact of mild-mod elev liver enzymes probably does not qualify as justification for both the cost and the danger of an antipsychotiic switch. But, that all has to be part of the equation - as is the number of non-psych meds that have hepatic metabolism.

For a medical pt with liver impairment who is not critically ill, I might add Invega, then begin tapering the dose of the other antipsychotic and watch to see if the enzymes indicate any benefit from the reduction in other antipsychotic.

But I'm NOT a C/L specialist.
 
From PharmaTimes:

US regulators open door to Schering-Plough’s antipsychotic Saphris
17 August 2009
The US Food and Drug Administration has issued a green light for Schering-Plough’s antipsychotic Saphris as a first-line treatment for schizophrenia and manic or mixed episodes associated with bipolar I disorder, marking the first time a psychotropic drug has won approval for both these indications simultaneously.

Regulators gave clearance to the drug, which acts on specific serotonin and dopamine receptors in the brain, after a comprehensive clinical trials programme showed that the sublingual pill induced significant improvements in the symptoms of schizophrenia as well as a significant reduction in the symptoms of bipolar mania compared to placebo.

Both the company and its investors will undoubtedly be thrilled by the news, particular as the markets for these two conditions are enormous, with schizophrenia affecting about 24 million people worldwide and bipolar I disorder about 1% of all adults.

Doctors have also welcomed news of a new treatment option for these complex illnesses, which, according to schizophrenia study author Steven Potkin, professor at the department of psychiatry and human behaviour at University of California, “can present clinical challenges for the physician”.

And as Roger McIntyre, associate professor of psychiatry and pharmacology at the University of Toronto, Canada, and lead author of the pivotal bipolar mania studies with the drug, pointed out: "Having a new FDA-approved treatment such as Saphris (asenapine) is important in these serious conditions because physicians need options to help manage their patients' symptoms”.

Competitive edge?
Analysts believe that Saphris, which was filed with European regulators under the brand name Sycrest in June, has the potential to do very well indeed particularly as it is associated with negligible weight gain and doesn’t seem to carry any cardiovascular safety issues, as some of the other atypical antipsychotics on the market do.

The company said it plans to make Saphris available throughout US pharmacies in the fourth quarter of this year.

By Selina McKee
 
From PharmaTimes:

US regulators open door to Schering-Plough's antipsychotic Saphris
17 August 2009
The US Food and Drug Administration has issued a green light for Schering-Plough's antipsychotic Saphris as a first-line treatment for schizophrenia and manic or mixed episodes associated with bipolar I disorder, marking the first time a psychotropic drug has won approval for both these indications simultaneously.

Regulators gave clearance to the drug, which acts on specific serotonin and dopamine receptors in the brain, after a comprehensive clinical trials programme showed that the sublingual pill induced significant improvements in the symptoms of schizophrenia as well as a significant reduction in the symptoms of bipolar mania compared to placebo.

Both the company and its investors will undoubtedly be thrilled by the news, particular as the markets for these two conditions are enormous, with schizophrenia affecting about 24 million people worldwide and bipolar I disorder about 1% of all adults.

Doctors have also welcomed news of a new treatment option for these complex illnesses, which, according to schizophrenia study author Steven Potkin, professor at the department of psychiatry and human behaviour at University of California, "can present clinical challenges for the physician".

And as Roger McIntyre, associate professor of psychiatry and pharmacology at the University of Toronto, Canada, and lead author of the pivotal bipolar mania studies with the drug, pointed out: "Having a new FDA-approved treatment such as Saphris (asenapine) is important in these serious conditions because physicians need options to help manage their patients' symptoms".

Competitive edge?
Analysts believe that Saphris, which was filed with European regulators under the brand name Sycrest in June, has the potential to do very well indeed particularly as it is associated with negligible weight gain and doesn't seem to carry any cardiovascular safety issues, as some of the other atypical antipsychotics on the market do.

The company said it plans to make Saphris available throughout US pharmacies in the fourth quarter of this year.

By Selina McKee

Yet another dopamine/serotonin blocker... I heard it on Sermo.. somehow I am not too excited. Havent been approached by pharma about it. I doubt it will go on our formulas for a while.
 
Having been in a position several times in the forensic hospital where only one med worked on a particular patient after several have failed, I think the more options we got the better.

I've seen some patients get better off of an old medication such as Trilafon, and Clozaril even at high doses didn't work. We have plenty of people where over 7 antipsychotics have been tried, and all failed, and the person is still very psychotic.

An added medication can offer at least another treatment possibility that may work where others have failed.

Hopefully science will one day be able to explain why only one particular medication works in some patients, when they are all working off of the same theory--D2 blockage or D2 & 5HT blockage.
 
http://www.tradingmarkets.com/.site/news/Stock News/2612431/

Oct 30, 2009 (Datamonitor via COMTEX) -- FRX | Quote | Chart | News | PowerRating -- Forest Laboratories, a US-based pharmaceutical company, and Gedeon Richter, a Hungarian pharmaceutical company, have reported positive topline results from a Phase IIb clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of acute exacerbation of schizophrenia.
For the primary endpoint, the positive and negative syndrome scale, the data showed that patients with schizophrenia treated with cariprazine experienced significant symptom improvement compared to placebo patients within the first week of treatment and at each subsequent time point studied, the two companies said.

Based on this latest schizophrenia data, subject to a complete review of the full results, and the previously announced Phase II results in patients suffering from acute mania associated with bipolar I disorder, the companies intend to initiate Phase III trials for both indications in early 2010.

According to Forest Laboratories, cariprazine is an orally active D3/D2 partial agonist with preferential binding to D3 receptors. Cariprazine is currently also undergoing Phase II clinical trials in patients with bipolar depressive disorder and as adjunctive therapy in major depressive disorder.

Erik Bogsch, CEO of Gedeon Richter, said: "We are very encouraged by these results as we believe that cariprazine has the potential to be a valuable new treatment option for people suffering from schizophrenia. These results are considered as a further step towards our commitment conducting original research in the field of central nervous system disorders, where our team has excellent expertise."


I see Forest trying to make a mint down the line with a cariprazine-escitalopram combo pill
 
http://www.miamiherald.com/business/nation/story/1381138.html


Labeling for ZYPREXA RELPREVV includes a requirement for the patient to be observed at a healthcare facility with ready access to emergency response services for at least three hours following each injection and to be accompanied to his or her destination upon leaving the facility.

http://www.zyprexarelprevv.com/index.jsp


Meet your new Lilly RELPREVV detailing team!

(Why do these drugs all need to have names made up by sci-fi authors?)
 
Q: Why do these drugs all need to have names made up by sci-fi authors?

A: data showing drugs sell better if there is an X or Y or Z in the name.


My new sleep medicine name is meant to imply you will have sex before falling asleep with this medicine:

XXXzzzzzzzzzz
 
A: data showing drugs sell better if there is an X or Y or Z in the name.


My new sleep medicine name is meant to imply you will have sex before falling asleep with this medicine:

XXXzzzzzzzzzz

Yes, but it's so much more expensive than my generic 'Zombien'.
(Side effects may include pallor, dark circles under eyes, and increased appetite for human brains.)
 
Yes, but it's so much more expensive than my generic 'Zombien'.
(Side effects may include pallor, dark circles under eyes, and increased appetite for human brains.)

Your side-effects vs mine.
You get what you pay for.
 
http://online.wsj.com/article/BT-CO-20100203-715003.html?mod=WSJ_latestheadlines

"TD Securities analyst Lennox Gibbs kept his 'reduce' rating on Labopharm, citing Trazodone's "unfavorable pharmacoeconomic profile for today's reimbursement environment." In a report, he said that without a head-to-head trial between OLEPTRO and generic Trazodone, it will be difficult to convince prescribers to switch to OLEPTRO from inexpensive generics.

Labopharm chief executive James Howard-Tripp said the drug's selling point goes beyond the convenience of a once-a-day pill, noting that only 4% of subjects in the OLPETRO trial dropped out due to drowsiness.

Drowsiness is a frequent complaint from patients taking generic forms of Trazodone, which are dosed multiple times a day. A label for one generic shows 41% of patients in a clinical trial reported drowsiness compared to 20% in the placebo group. The label for OLEPTRO says 46% of patients reported drowsiness versus 19% in the placebo group."

http://www.docguide.com/news/content.nsf/news/852576140048867C852576BF00568A4E


"There's a large body of evidence demonstrating the efficacy of trazodone in the treatment of MDD," said Stephen Stahl, MD, University of California, San Diego School of Medicine, San Diego, California. This novel formulation of trazodone "effectively treats depression and provides a tolerable adverse event profile," he added.

The efficacy of extended-release trazodone was demonstrated in an 8-week, randomised, double-blind, placebo-controlled, multicentre study in patients with unipolar major depressive disorder. The primary efficacy endpoint of the study was to compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of the study in the treated group versus the placebo group. The results of this study, which are published in the May 2009 issue of Psychiatry, include the following:

· Statistical significance was achieved for the primary endpoint (P = .012)
· The overall discontinuation rate in the study was 25%, with 21% in the placebo group and 30% in the trazodone group.

In this trial, the most common adverse events associated with extended-release trazodone were somnolence/sedation, dizziness, constipation, and blurred vision. Four percent of patients in the trazodone group discontinued treatment due to somnolence or sedation.

"Our research in the clinical study leading up to FDA approval showed that [extended-release trazodone] was well tolerated and demonstrated a significantly greater improvement in the HAMD-17 primary efficacy endpoint over placebo," said Dr. David Sheehan, MD, Depression and Anxiety Disorders Research Institute, University of South Florida College of Medicine, Tampa, Florida. "When given at the recommended daily dose range, [extended-release trazodone] was an appropriate monotherapy for patients with MDD."
 
http://www.bioworld.com/servlet/com...?next=bioWorldHeadlines_article&forceid=53555

AZ-004, an inhalable form of the anti-psychotic loxapine, currently is under FDA review for the treatment of agitation in patients with schizophrenia or bipolar disorder.

The other two products affected by the Symphony arrangement are AZ-104 (Staccato loxapine) and AZ-002 (Staccato alprazolam).

Is AZ-002 Inhaled Xanax??
Remember, a drug's addictiveness is often related to the speed of onset AND the speed of withdrawal. Part of the reason cigarettes and crack are so addictive is that the onset is nearly instantaneous and the withdrawal (esp w/ crack) is nearly as fast.
When Xanax first came out it was touted as Non-addicting BECAUSE of its speed?!
 
http://www.bioworld.com/servlet/com...?next=bioWorldHeadlines_article&forceid=53555

AZ-004, an inhalable form of the anti-psychotic loxapine, currently is under FDA review for the treatment of agitation in patients with schizophrenia or bipolar disorder.

The other two products affected by the Symphony arrangement are AZ-104 (Staccato loxapine) and AZ-002 (Staccato alprazolam).

Is AZ-002 Inhaled Xanax??
Remember, a drug's addictiveness is often related to the speed of onset AND the speed of withdrawal. Part of the reason cigarettes and crack are so addictive is that the onset is nearly instantaneous and the withdrawal (esp w/ crack) is nearly as fast.
When Xanax first came out it was touted as Non-addicting BECAUSE of its speed?!

I'm betting the cocaine/alprazolam combo is gonna be a popular one with my gang... :rolleyes:
 
http://www.portfolio.com/views/blog...mone-may-treat-autism-french-researchers-say/

French researchers say they may have discovered a breakthrough in treating autism with a hormone that is believed to help bond mothers and their babies.
A study of 13 patients (mostly adults) with mild forms of autism found that inhaling oxytocin, a hormone active in social behaviors, helped attentiveness in a couple of experiments....

What about using oxytocin to increase Altruism? Would small doses of oxytocin (in a form resistant to stomach acid) put into the water supply do more for society than flouride? Surely, getting us to care about one another would reduce abuse/violence in our society. :rolleyes:
 
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