FDA Panel Votes To Approve Orexigen Diet Pill
8 CommentsBy Ed Silverman // December 7th, 2010 // 4:49 pm
In a surprise move, the FDA’s Endocrinologic and Metabolic Advisory committee voted 13-to-7 to recommend that Orexigen Therapeutics’ Contrave diet pill be allowed on the market. If the agency follows the advice, which is not guaranteed, Contrave would become the first new prescription diet drug to reach US consumers since 1999, when the FDA approved Roche’s Xenical. The panel, however, also voted 11-to-8 that additional studies are needed to ascertain cardiovascular risks.
Nonetheless, the recommendation has the potential to drastically change the weight-loss market and, perhaps, put a dent in the burgeoning population of obese people, which has become a public health issue. Despite the clamoring for new diet tools, the same FDA panel earlier this year bounced two other newly developed drugs - Qnexa from Vivus and Arena Pharmaceuticals’ Lorqess - over safety concerns. Investors are now encouraged enough to send Arena shares up in after-hours trading.
Safety issues have plagued prescription diet drugs for more than a decade. In 1997, Pfizer’s Wyeth recalled Pondimin, which was one-half of the fen-phen combo, and its chemical cousin, Redux, over serious heart and lung side effects. Xenical, also sold over-the-counter as Alli by GlaxoSmithKline, soon followed, but offered little benefit and uncomfortable side effects (specifically, orange undies). And Meridia was also available for many years, although the FDA recently forced Abbott Labs to withdraw the pill (see here). Safety concerns also prevented Sanofi-Aventis from pursuing approval for its Acomplia drug.
Prior to the meeting, FDA staffers expressed ambivalence about Contrave’s effectiveness. Four studies conducted by Orexigen demonstrated overweight patients lost, on average, 4.2 percent more weight than patients taking a placebo. On the other hand, this falls short of the FDA guideline that there should be at least a 5 percent difference in weight loss between these groups. The pill did meet a second effectiveness measure - at least 35 percent of patients, twice the proportion of those on the placebo, lost at least 5 percent of their weight. The FDA guidelines say a diet drug can be considered effective if it meets this requirement
Contrave combines the Wellbutrin antidepressant and a sustained release form of naltrexone, an opioid blocker used to treat addictions to alcohol and painkillers.
industry insider
In the specialty pharma biz we used to call this “yesterday’s drugs tomorrow”.
Ken Kramer
Based on what I read in the briefing documents, this was a surprise. Primarily because the magic 5% weight loss was not achieved, despite exceeding the 35% level.
My gut tells me this was passed because it is two known entities, and if this was a NME, it may not have due to the modest efficacy and safety questions.
However, it is not a done deal yet.
Lesson Learned - the more I think I know what FDA is going to do, the less I know.
-K
Rx consult
So why no just prescribe generic wellbutrin and natrexone? Do we really need a combo pill that will likely cost significantly more?
industry insider
Rx Consult, it would not be possible to substitute the generic components because the dosages used in the Contrave combination product for both naltrexone and buproprion are different from the standard dosages of each of the single agents and are thus patent protected, both individually and as components of the combination product.
RegMan
Assuming Contrave gets approved, which is by no means certain, it will be interesting to see if compounding pharmacies try to have a field day with it. They are already compounding low dose naltrexone for other uses, and the buproprion dose isn’t too far off that which is generically available. If they do, I’m sure Orexigen will do its part to reduce unemployment (of lawyers).
industry insider
RegMan, good suggestion. However, at least in my state, because of liability considerations compounding pharmacies have virtually out of existence. Moreover, a thorough innovator will patent all conceivable dosage forms at the time of the original patent filing, thus a compounded product would most likely infringe that type of patent as long as it is valid.
JaT
Isn’t one of these compounds going to make it horrible to drink alcohol? Maybe that’s how it works. Who wants to go out to dinner if they can’t enjoy a glass of pinot?
;)
Sincerely though, it’s one thing I hate about the drugs I take and my condition, not that I have ever been a big drinker, but I did appreciate sampling a good red in social settings. It’s so not fair. I can’t drink at all.
Compliance should be an interesting dilemma.
Ken Kramer
JaT
In this case I think you are mistaken. The drug you are thinking about is Antabuse (disulfiram), which is a drug given to persons who abuse alcohol and causes them to feel pretty bad if they consume alcohol. Naltrexone works by blocking opiate receptors which are involved in the rewarding effects of reinforcing behaviors such as food, drugs and alcohol.
No need to worry unless you are dependent on some drug of abuse.
Ken