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June 29, 2006
Rimonabant Arrives
Posted by Derek
Well, although Sanofi-Aventis still hasn't been very forthcoming on their FDA problems, their CB-1 antagonist Accomplia (rimonabant) has now been approved in Europe, and is already on sale in the UK. (S-A still say that they expect it to make it through in the US by the end of the year).
This article from Bloomberg is an excellent summary of the situation. No new obesity drugs have been approved for almost ten years, and potential sales of a safe and effective one are almost impossible to estimate. But there's room to argue about how effective rimonabant is, and (as with any drug) there's always room to argue about safety. And that's particularly true in what some people are already calling the post-Vioxx era.
The article makes some of the same points that I've made here before: new therapies and new mechanisms have risks, and there is no way that we (the drug industry and the regulatory authorities) can get rid of them. We can test for the big ones and read the signs for the smaller ones, but if a new drug is going to taken by millions of people for long periods, things will happen that no one ever saw during the clinical trials.
I hope, for Sanofi's sake and everyone else's, that there's nothing weird lurking down in the statistical weeds this time. But you can be absolutely sure that the company is holding its breath. We all do. It doesn't help.
Comments (12)
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1. Speedy on June 30, 2006 12:52 PM writes...
Derek, would you mind expanding on the effectiveness and risks of these various "diet drugs" vs. plain old amphetamine?
Permalink to Comment2. Luke, I am your fungus! on June 30, 2006 2:12 PM writes...
Risk vs effectiveness: Smoking Rimonabant can be fateful...
Permalink to Comment3. Joe Guy on June 30, 2006 2:58 PM writes...
Or....
How about expanding upon olde timey pharmacology ala Albert Hoffman or those that "discovered" amphetamines.
Used to be the pharmacologist was his own subject, not the rat. Guess they dont teach those methods anymore in school!
Permalink to Comment4. Speedy on June 30, 2006 6:30 PM writes...
Haha Joe. Now, seriously, whats in the pipeline that will work better than dexadrine+tricor, or is that combo the best that can be done?
Permalink to Comment5. Handles on June 30, 2006 8:39 PM writes...
The old post about CB-1 agonists and neuroprotection was interesting. More on the same at the BBC:
Permalink to Commenthttp://news.bbc.co.uk/2/hi/uk_news/england/devon/5130472.stm
6. Donny on July 1, 2006 8:09 AM writes...
I've been studying rimonabant for several years now as part of my work as a pharma industry market analyst.
The dollar potential of the obesity market is staggering. Take just the US, for example:
1/3 of the population is overweight
1/3 of the population is obese
that's 200 million potential patients.
If we assume that just 1% of this patient population will try rimonabant for 6 months (about the average amount of time that patients tried Xenical and Meridia), that's 2 million patients X 180 days of treatment X $3 per day of treatment = $1 billion in US sales of rimonabant in 6 months...that's blockbuster status.
And there are estimates out there that $30 billion plus dollars are spent in the US alone each year on weight loss products and services (diet foods, diet groups, OTC drugs, gyms, gastric bypass procedures, etc.)--this tells you what the potential can be for a safe and effective means of causing weight loss.
Of course this is an oversimplification, and the real picture is much more complicated. You have to factor in reimbursement (will HMO's pay for something they still consider to be a lifestyle issue rather than a medical issue?), the willingness of physicians to prescribe a new drug with a novel mechanism of action (most prefer to wait and see until some time has passed and the safety and efficacy is better known; this is doubly true in the years post-PhenFen and Vioxx), how hungry patient demand will be, whether metabolic syndrome will become more formally recognized as a disease entity, etc.
However, other weight loss drugs over the years have received a lot of hype too, and they have not done well in the marketplace, because they had only modest efficacy, not so good side effect profiles, were expensive, and were not reimbursed. Rimonabant improves upon the safety and efficacy profiles of existing obesity drugs only modestly, and it remains to be seen whether the market will reward these modest improvements.
Permalink to Comment7. Polly on July 19, 2006 10:13 PM writes...
I've been waiting for this drug to get through the FDA. Been 'fat' all my 56 years but lost 87 lbs on Phen/Fen and never felt better. Not a thing happened to me and I still struggle to keep it off.
The problem with EVERY drug is if the word 'DIET' is attached to it - the little blonde bimbo's of the world will have the media all over it.
Then, we're all fat lazy slobs and they find someone who has a reaction to the drug and all bets are off!
Like no one ever died from being allergic to penicillin??
We're all grown ups; we should be allowed to make our own decisions!!!
Thanks for listening.
Permalink to Comment8. BKay on July 23, 2006 2:47 PM writes...
I have just joined a double blind rimonabant study. So far I am not positive at this point that I am taking the drug but having some mild symptoms that I don't usually have. Not ready to jump to any conclusions. This is a new study (USA) that began recently. It was recommended to me by my physician for metabolic syndrome type sxs. I am at high risk. I am not obese but some overweight. Most might not even consider me overweight but I am enough to increase my risk due to inherited factors. I am hoping to lose some weight, decrease cholesterol, lower blood pressure, increase good cholesteral and other touted benefits. We shall see.
Permalink to Comment9. mairead on August 15, 2006 11:57 AM writes...
My doctor won't prescribe any diet pill, so can someone tell me how do I find a doctor who will. I live in Palm Desert., California. I have been told that buying it on the net is not a good idea since the reliability is not guaranteed.
Permalink to Comment10. mairead on August 15, 2006 11:57 AM writes...
My doctor won't prescribe any diet pill, so can someone tell me how do I find a doctor who will. I live in Palm Desert., California. I have been told that buying it on the net is not a good idea since the reliability is not guaranteed.
Permalink to Comment11. Judy on June 22, 2007 7:05 PM writes...
I AM PARTICPATING IN A TRIAL FOR THIS DRUG THRU dESERT MEDICAL CLINICAL RESEARCH..I'M NOT SURE IF THE STUDY IS CLOSED- LENGTH IS 3 YRS INCLUDES THE TRIAL DRUG, MEDICAL MONITORING & TESTING IF YOU QUALIFY. SOUNDS LIKE YOU WOULD. GIVE THEM A CALL.
Permalink to Comment12. IamUsuallyWright on July 6, 2008 2:29 PM writes...
There is certainly some unknown risks with any drug, and with Rimonabant the know risks are not negligable. However, those risks must always be weighed against the potential benefit of the drug.
Just as an aside, Rimonabant works very well in combination with other drugs since you don't have to worry about anything else having much effect on CB1 receptors.
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