Botox now FDA approved for UE spasticity

[Finally M3]

May hopefully, positively effect coverage for those who need.

IRVINE, Calif., Mar 09, 2010 (BUSINESS WIRE) -- Allergan, Inc. (NYSE: AGN) today announced that the United States Food and Drug Administration (FDA) has approved BOTOX® (onabotulinumtoxinA) for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity.

Spasticity is a debilitating condition impacting approximately 1 million Americans1, many of whom suffer from spasticity in the upper limbs following a stroke. Upper limb spasticity may also occur following a spinal cord or traumatic brain injury or in patients affected by multiple sclerosis or adults with a history of cerebral palsy.

Although not a life-threatening condition, upper limb spasticity can be severely debilitating and painful, producing disfiguring muscle contractions that can result in stiff, tight muscles in the elbow, wrist and fingers, or a clenched fist. This stiffness hinders a patient's ability to perform simple tasks, such as dressing or washing the hand, and often leaves the patient dependent on a caregiver to help with simple activities.

"Upper limb spasticity can manifest weeks, months or even years after the original injury, possibly after a patient has stopped seeing a neurologist, physiatrist or their rehabilitation specialist, which is why it is severely undertreated and there's a low awareness of the condition," said Mitchell F. Brin, MD, Allergan's Senior Vice President Global Development, Chief Scientific Officer, BOTOX®. "The approval of BOTOX® marks another important evolution in medical care, as we look to raise greater recognition and understanding of upper limb spasticity among patients affected by the condition, and refer them to a neurologist or physiatrist to explore their various treatment options."

In patients diagnosed with upper limb spasticity, BOTOX® is injected by a trained specialist directly into the affected muscles, blocking overactive nerve impulses that trigger these disabling contractions to reduce the severity of increased muscle tone in the elbow, wrist and fingers. In clinical studies, the efficacy of BOTOX® persisted up to three months on average. BOTOX® is the first and only neurotoxin approved by the FDA for the treatment of upper limb spasticity.

Clinical Studies Evaluating BOTOX® For the Treatment of Upper Limb Spasticity

Allergan has conducted multiple studies evaluating the use of BOTOX® to treat upper limb spasticity, including three double-blind, placebo-controlled studies, two of which were published in The New England Journal of Medicine,2 and Archives of Physical and Medical Rehabilitation3.

The first double-blind, placebo-controlled trial compared the safety and efficacy of BOTOX®treatment (200-240 units (U)) with placebo over a 12-week period in 126 patients who had suffered a stroke at least 6 months prior and experienced increased wrist and finger flexor tone (scores of at least 3 for wrist flexor tone and at least 2 for finger flexor tone based on the Ashworth Scale). The Ashworth Scale is a globally accepted measure of muscle tone4, which rates passive movement from 1 (normal muscle tone) to 4 (extreme increase in muscle tone).

The study found that BOTOX® neurotoxin produced a statistically significant reduction in both wrist flexor and finger flexor muscle tone seen at the week six primary endpoint (P < .05 versus placebo).5,6 Further, evaluation by the Physician's Global Assessment score, an investigator's measure of a patient's response to treatment, correlated with the Ashworth scores, showing a statistically significant difference favoring BOTOX® versus placebo at the primary endpoint (week 4).7,8

The second study compared three doses of BOTOX® (360 U, 180 U, 90 U) with placebo over 24 weeks in 91 patients at least 6 weeks post-stroke with increased elbow flexor and wrist flexor tone (a score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone based on an expanded Ashworth Scale). 9,10 In this study, the 360 U group achieved statistically significant reduction versus placebo in wrist flexor tone at the week 6 primary endpoint.

Similar results were observed in a clinical study that compared the same dosing regimens of BOTOX® (360 U, 180 U, 90 U) with placebo over 12 weeks in 88 patients at least 6 weeks post-stroke with increased elbow tone and wrist and/or finger tone (scores of at least 2 for elbow flexor tone and at least 3 for wrist and/or finger flexor tone based on the Ashworth Scale)11. This study showed BOTOX® decreased muscle tone and achieved statistically significant decreases in wrist flexor tone, finger flexor tone and elbow flexor tone in the 360 U group at week 412.

"For patients who suffer from upper limb spasticity, simple activities can be so challenging they must rely on a caregiver to pry open their hand and stretch back their fingers so they can wash their hands or get dressed," said Allison Brashear, M.D., Professor and Chair, Department of Neurology at Wake Forest University Baptist Medical Center in Winston-Salem, NC. "In the clinical studies, we saw improvement in muscle tone in patients injected with BOTOX®, which was maintained for up to three months with no further injection."

In the double-blind, placebo-controlled studies of BOTOX® for the treatment of upper limb spasticity, the most common adverse events occurred in less than 7 percent of patients and included pain in extremity, fatigue, muscle weakness, nausea and bronchitis .13

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[RUOkie]

It is about time. Now at least the reps can legally speak with us, and the Allergan patient assist program can be used for spasticity.

 

[ml2001]

It is about time. Now at least the reps can legally speak with us, and the Allergan patient assist program can be used for spasticity.

We had an Allergan rep talk to us about something else today during noon lecture, but she mentioned that not only to what RUOke mentioned above, they now would be able to offer training for residents to get everyone up to speed with the skills. She mentioned that our program is already providing required skills to do UE botox but that lot of residency programs out there don't do it. She is planning to bring in a UE manikin to practice, which I'm eagerly waiting.....

-ML

 

[Ludicolo]

We had an Allergan rep talk to us about something else today during noon lecture, but she mentioned that not only to what RUOke mentioned above, they now would be able to offer training for residents to get everyone up to speed with the skills. She mentioned that our program is already providing required skills to do UE botox but that lot of residency programs out there don't do it. She is planning to bring in a UE manikin to practice, which I'm eagerly waiting.....

-ML

So I’m intrigued… some programs are still allowing drug reps to talk to residents, let alone TRAIN them? I thought most academic centers were trying to put the kibosh on this?

 

[ml2001]

So I’m intrigued… some programs are still allowing drug reps to talk to residents, let alone TRAIN them? I thought most academic centers were trying to put the kibosh on this?

I should have been more clear about this. She was giving us a seminar on how to deal with the real world in terms of marketing yourself as a doctor, interview tips, what to look for when looking for a job in private practice and so on. She wasn't talking about any educational stuff.

And as for her bringing the UE manikin, our attending will do all the teaching. She will only provide us with the UE manikin for us to practice. Hope this clears any doubts...

-ML

 

[RUOkie]

I should have been more clear about this. She was giving us a seminar on how to deal with the real world in terms of marketing yourself as a doctor, interview tips, what to look for when looking for a job in private practice and so on. She wasn't talking about any educational stuff.

And as for her bringing the UE manikin, our attending will do all the teaching. She will only provide us with the UE manikin for us to practice. Hope this clears any doubts...

-ML

Then why does your attending not teach you with actual patients.

DO NOT TRUST DRUG REPS!!!

Especially when it comes to marketing your practice etc. They have a vested interest to steer you towards their product. (and as a point of disclosure, I work for Pfizer as a speaker --But I make a point of separating the work I do from my actual practice management)

 

[ml2001]

Then why does your attending not teach you with actual patients.

DO NOT TRUST DRUG REPS!!!

Especially when it comes to marketing your practice etc. They have a vested interest to steer you towards their product. (and as a point of disclosure, I work for Pfizer as a speaker --But I make a point of separating the work I do from my actual practice management)

We do get lot of teaching in the Stroke/TBI clinics in Botox, but the session with the manikin is geared more so towards those junior residents who haven't done any clinic yet. In addition, I don't think getting extra training is a bad idea even for senior residents.

As far as the rep steering our clinics towards using their version of Botox, I believe most of the clinics at our university (both rehab and non-rehab clinics like Neurology) that use Botox already use this company' version. I'm sure everyone looked at other options before deciding on using this Botox.

-ML

 

[Finally M3]

Actually, the Future Steps program has little to nothing to do with creating a spasticity practice, and really does talk about what to look for in jobs, contracts, networking, etc.

Although, with the economy cutbacks, the fancy steak/all you can swill wine dinner associated with the Future Steps lectures morphed into catered dinners for the workshops, from what I hear.

 

[PMR 4 MSK]

We do get lot of teaching in the Stroke/TBI clinics in Botox, but the session with the manikin is geared more so towards those junior residents who haven't done any clinic yet. In addition, I don't think getting extra training is a bad idea even for senior residents.

As far as the rep steering our clinics towards using their version of Botox, I believe most of the clinics at our university (both rehab and non-rehab clinics like Neurology) that use Botox already use this company' version. I'm sure everyone looked at other options before deciding on using this Botox.

-ML

There is only one Botox - that's the brand name. There are 2 other botulinum toxin preparations available, but both are having difficulty with doctors getting reimbursed for using it. Botox is only ordered through Allergan, the manufacturer. There is no need for middle-men.

I've found the drug reps for Botox to be quite helpful. They simply want me to be able to use their product more, and that means having ore spasticity patients available. I've never felt they were pushing it as first line therapy or marketing it inappropriately. Allergan has a very helpful 800# to assist with reimbursement that has saved me more than once.

I'm very selective in my use of Botox. Generally, I use it only in UMN disorders. Rarely do I try it for other things.

I think a mannequin for training purposes is great for those with limited experience. It should always be done with EMG guidance in clinical practice.

The reps have offered me several times to have a "proctoring" where they'll pay someone to help me learn more on the job. I tell them I should be the one proctoring others.

 

[Ludicolo]

DO NOT TRUST DRUG REPS!!!

Especially when it comes to marketing your practice etc. They have a vested interest to steer you towards their product. (and as a point of disclosure, I work for Pfizer as a speaker --But I make a point of separating the work I do from my actual practice management)

RUOkie – how successful are you really at separating the two? Neither judging nor attacking. Just asking.

 

[ml2001]

There is only one Botox - that's the brand name. There are 2 other botulinum toxin preparations available, but both are having difficulty with doctors getting reimbursed for using it. Botox is only ordered through Allergan, the manufacturer. There is no need for middle-men.

I've found the drug reps for Botox to be quite helpful. They simply want me to be able to use their product more, and that means having ore spasticity patients available. I've never felt they were pushing it as first line therapy or marketing it inappropriately. Allergan has a very helpful 800# to assist with reimbursement that has saved me more than once.

I'm very selective in my use of Botox. Generally, I use it only in UMN disorders. Rarely do I try it for other things.

I think a mannequin for training purposes is great for those with limited experience. It should always be done with EMG guidance in clinical practice.

The reps have offered me several times to have a "proctoring" where they'll pay someone to help me learn more on the job. I tell them I should be the one proctoring others.

Just to make my statements technically correct, I meant botulinum toxin when I said Botox.

The Botox rep that we regularly get to meet frequently is also quite helpful. I'm just glad that they brought "Elvis" recently for us to practice even though he was sick and the computer wasn't working properly. She said she will bring him back once its fixed. However, she will for now bring the UE for us to practice on.

At our residency program, I have seen Botox used for post-stroke pts and CP sometimes. I haven't seen it used in TBI yet in my limited exposure so far. Almost all the time, it is in the UE's although there were couple of LE's that I have seen.

-ML

 

[RUOkie]

RUOkie – how successful are you really at separating the two? Neither judging nor attacking. Just asking.

I speak for Lyrica, where most of the talks are for Fibromyalgia. Do you really think I want to fill up my practice with FM pts? I don't know about your area, but 2 weeks ago, Pfizer wanted their speakers to do radio broadcasts toward the general popluation. I refused. I volunteered to speak to docs for them because I knew the product worked. BUT, I do not let the reps dictate what my practice looks like. Heck, I don't even take Lyrica samples in my office cause I don't want to keep a log of controlled substances.

Finally, when people look at my prescribing history (which we know is not supposed to be given to the reps, but the pharmacies do disclose), I prescribe more Cymbalta than I do Lyrica. And I have no relationship with Lilly.

 

[Ludicolo]

I speak for Lyrica, where most of the talks are for Fibromyalgia. Do you really think I want to fill up my practice with FM pts? I don't know about your area, but 2 weeks ago, Pfizer wanted their speakers to do radio broadcasts toward the general popluation. I refused. I volunteered to speak to docs for them because I knew the product worked. BUT, I do not let the reps dictate what my practice looks like. Heck, I don't even take Lyrica samples in my office cause I don't want to keep a log of controlled substances.

Finally, when people look at my prescribing history (which we know is not supposed to be given to the reps, but the pharmacies do disclose), I prescribe more Cymbalta than I do Lyrica. And I have no relationship with Lilly.

Appreciate the response.

I don't like fibro either.