"New" drug: Intermezzo (aka can't I just cut my generic Ambien in half)

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KARM12

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http://drugtopics.modernmedicine.co...Article/detail/750756?contextCategoryId=40159


FDA approves Intermezzo which is low dose Ambien for pts with middle of the night awakenings. The doses are 1.75mg or 3.5mg...nice marketing. I don't see why you can't just cut a generic zolpidem in half...

Discuss.

Members don't see this ad.
 
It is a sublingual tablet. Not the same as cutting a zolpidem in half.

Still seems a bit pointless to me. If you don't think you'll sleep well just take a full tablet before trying to sleep.
 
Members don't see this ad :)
I like how they said its the first sleep med to be approved for waking up at night.. not true. Yea, thats what Sonata is for.

Dumb a*s*s meds being approved.. No advancement in real drug development in such a long time

Juvisync.. gimme a f*ckn break
 
Does the FDA have to review this NDAs? Can't they just say "hey sorry, we're busy trying to figure out how to prevent shortages of chemo meds, we can't review this BS application"?

Stupid.
 
Well what about that new combo ibu 800/famotidine 26.4mg that sells for about $200/60 tabs. I mean if they can even sell a little bit of that crap they are geniuses.
 
Does the FDA have to review this NDAs? Can't they just say "hey sorry, we're busy trying to figure out how to prevent shortages of chemo meds, we can't review this BS application"?

Stupid.

I totally agree, but I think that is part of the reason the manufacturers pay for NDA's, so the FDA can staff correctly to handle the applications in the first place.
 
Whenever I worked at the satellite pharmacy at my old job, I would often turn on our local NPR station and early in the afternoon, they had a locally produced classical music program called - you guessed it - "Intermezzo".

:idea:
 
Does the FDA have to review this NDAs? Can't they just say "hey sorry, we're busy trying to figure out how to prevent shortages of chemo meds, we can't review this BS application"?

Stupid.

The place where I work is not as worried about the chemo drug shortage as we are about the inability to get fentanyl, sufentanil, and now morphine. 😡

Several years ago, I went to a presentation on Civil War medicine by a doctor who is really into medical history (like me) and he said that the phrase "bite the bullet" is based on exactly that - and had a bullet from that era with a tooth mark in it. It was a homemade bullet that looked like, and had the consistency of, fossilized chewing gum. That tooth mark, he added, may well have been the only tooth that soldier had.
 
I was always under the impression that a new drug had to show benefit over existing therapy. Guess not.

Correct. They have to show non-inferiority, not superiority. And even the non-inferiority is over a range. Not exactly a strict system, though how much power do you want to give the FDA to control what products enter the market place?
 
This is absurd, and part of the reason why healthcare costs so damn much in America. People will be suckered into buying this and docs will be suckered into prescribing it. Oh well.

I do like the name though, very catchy.
 
Members don't see this ad :)
It is a sublingual tablet. Not the same as cutting a zolpidem in half.

Still seems a bit pointless to me. If you don't think you'll sleep well just take a full tablet before trying to sleep.

True it is SL, but in all honesty you can just chew a half of a zolpidem RR. My junkies told me this is a good way to knock yourself out quickly.
 
Well what about that new combo ibu 800/famotidine 26.4mg that sells for about $200/60 tabs. I mean if they can even sell a little bit of that crap they are geniuses.

Aren't hospitalizations from NSAID induced GI bleeds an issue still? Do you think this will help?
 
Correct. They have to show non-inferiority, not superiority. And even the non-inferiority is over a range.
This. There are a plethora of "me too" drugs on the market that add nothing in terms of efficacy but do add a substantial cost over other drugs in the same class that have gone generic.

Not exactly a strict system, though how much power do you want to give the FDA to control what products enter the market place?
Well, we already have a Wild West type of situation with the herbal medicine and dietary supplement products that are not FDA-regulated. As sympathetic as I am to libertarian ideals, and as onerous as FDA regulations can be, it ain't like corporate pharma is watching out for the consumer. We won't even go into the unabashed fleecing of uninformed consumers done by companies that produce homeopathic remedies.
 
Well, we already have a Wild West type of situation with the herbal medicine and dietary supplement products that are not FDA-regulated. As sympathetic as I am to libertarian ideals, and as onerous as FDA regulations can be, it ain't like corporate pharma is watching out for the consumer. We won't even go into the unabashed fleecing of uninformed consumers done by companies that produce homeopathic remedies.

It is an interesting dilemma to be sure. I am not a huge fan of the IDEA of the FDA being able to deny NDA's that are shown to be safe and efficacious, but it is a shame that it is easier (cheaper) to repackage an old drug than it is to develop a new one to get that precious patent. And as long as that is the case I don't see anything changing.

One thing that might work is longer patents for novel drugs and shorter patents for me too drugs, with new formulations of existing drugs the shortest patent time of all. I wonder if such a system is possible/reasonable.
 
One thing that might work is longer patents for novel drugs and shorter patents for me too drugs, with new formulations of existing drugs the shortest patent time of all. I wonder if such a system is possible/reasonable.
The fact that it's so reasonable means it's highly unlikely to be possible. 😉
 
Why not simply go back to some good old-fashioned sleep aids instead of more drugs. . . or in this case more of the same drugs with a new name and a high price?.

A warm glass of milk at bedtime; a cool, dark room; no television or radio or computer or ipods or iphone.

Ahhh. Think I'll sleep just fine tonight!
 
It's getting ridiculous for real! I thought I was the only one wondering what in the world is up withthe FDA....adding medications to classes that already have 6 drugs...it's crazy......we do not need Edarbi, for crying out loud....and we certainly do not need Edabyclor.
Trajendta? It hasn't even been a year now Jentadueto? Get real. Driving up healthcare costs for no damn reason....
 
I'm surprised at the general dismissiveness and what ultimately amounts to inexperience at best and ignorance at worst. Middle insomnia is a separate and distinct type of insomnia. Although most people think of insomnia as late onset sleep caused by anxiety or caffeine, the presentation and causality of middle insomnia is often different. The patient has no trouble going to sleep and falling asleep at a regular time. The trouble is not only waking before the night and sleep is over, but falling back to sleep.
It could be caused by certain antidepressants, Parkinson's meds, and other similar treatments for chronic conditions. Therefore, a patient can't just take something like an Ambien at bedtime. Not only is it unnecessary but some of these patients are sensitive to hypnotics, get a hang over, are sensitive to dosages, and really don't need to shoot a target with a canon. For their needs, falling back asleep faster but for a shorter duration is just what they're looking for.
I guess since this kind of detailed info can't be memorized from a textbook or iPhone app and one is unlikely to come across this kind of dual diagnosis while doing clinical rotations it might not have occurred to some posting here. The reality is that although drug ever greening and such exists, if there's a new drug on the market it's because there's a significant patient population who needs it. Amitiza and Linzess aren't the same drug, for instance. And even if they appeared to be, each patient is going to have their own experience with a med, and the data is just going to show what it wants to.
 
I'm surprised at the general dismissiveness and what ultimately amounts to inexperience at best and ignorance at worst. Middle insomnia is a separate and distinct type of insomnia. Although most people think of insomnia as late onset sleep caused by anxiety or caffeine, the presentation and causality of middle insomnia is often different. The patient has no trouble going to sleep and falling asleep at a regular time. The trouble is not only waking before the night and sleep is over, but falling back to sleep.
It could be caused by certain antidepressants, Parkinson's meds, and other similar treatments for chronic conditions. Therefore, a patient can't just take something like an Ambien at bedtime. Not only is it unnecessary but some of these patients are sensitive to hypnotics, get a hang over, are sensitive to dosages, and really don't need to shoot a target with a canon. For their needs, falling back asleep faster but for a shorter duration is just what they're looking for.
I guess since this kind of detailed info can't be memorized from a textbook or iPhone app and one is unlikely to come across this kind of dual diagnosis while doing clinical rotations it might not have occurred to some posting here. The reality is that although drug ever greening and such exists, if there's a new drug on the market it's because there's a significant patient population who needs it. Amitiza and Linzess aren't the same drug, for instance. And even if they appeared to be, each patient is going to have their own experience with a med, and the data is just going to show what it wants to.

Did you get that straight from the drug manufacturer? Intermezzo is literally half strength Ambien. Cut an Ambien in half (like any halfway competent pharmacist would instruct rather than dispensing Intermezzo) and you get the same result at like 1% of the total cost of a new brand name drug. You can't really learn about that from some manufacturer pamphlet though. Learn something about pharmacy before you post next.
 
The reality is that although drug ever greening and such exists, if there's a new drug on the market it's because there's a significant patient population who needs it. Amitiza and Linzess aren't the same drug, for instance. And even if they appeared to be, each patient is going to have their own experience with a med, and the data is just going to show what it wants to.

I just about snorted my milk out of my nose at this! Thanks for the good laugh.
 
Probably not good news for Intermezzo's marketing plans...


FDA orders lower doses of Ambien and other sleeping pills to prevent morning drowsiness
By Associated Press,January 10, 2013

The Food and Drug Administration is requiring makers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting patients face a higher risk of injury due to morning drowsiness.

The agency said Thursday that new research shows that the drugs remain in the bloodstream at levels high enough to interfere with alertness and coordination, which increases the risk of car accidents.

Regulators are ordering drug manufacturers to cut the dose of the medications in half for women, who process the drug more slowly. Doses will be lowered from 10 milligrams to 5 milligrams for regular products, and 12.5 milligrams to 6.25 milligrams for extended-release formulations.


Read the full article here: http://articles.washingtonpost.com/2013-01-10/business/36272892_1_fda-staff-ambien-drug-evaluation
 
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