Posts tagged ‘OREX’

CONTRAVE Revisited

Yes, we know that all of the bells have tolled for Contrave – even the fat lady’s final notes have faded, but we feel compelled to comment on the Orexigen announcement that they have put their plans for Contrave on hold because they failed to convince the FDA that their plan to study the potential cardiovascular effects was sound.  Equally interesting to us was the comment made that such action by the FDA challenges the development of obesity drugs in the US.

We have been consistent in our opinion of the three obesity drugs that were before the FDA during the past year.  Uniformly, they either didn’t meet the very lenient efficacy requirement or in fact failed it.  Recall our cupcake commentary – 5% weight loss over the course of a year for a 200 pound person is the equivalent of one cupcake a week.  Remember also, it is all about benefit risk with the FDA.  With such a lenient efficacy requirement, it is understandable that the FDA expects a very clean safety profile.

There is a case for the continued evaluation of obesity drugs in the US.  With all the reports confiming that we are a society that is becoming more and more obese, dieting and will power don’t seem to be able to control the trend.  So how about developing a drug that is as effective as gastric by pass with 25% weight loss not uncommon in the year following surgery.  Such a weight loss with the accompanying reduction in co-morbidities associated with obesity may just get the benefit risk to a position that the FDA finds acceptable.

CONTRAVE – Advisory Committee Meeting

On Dec 7, 2010, Orexigen Therapeutics (OREX) will present the data on CONTRAVE to an FDA Advisory Committee seeking its recommendation for use of CONTRAVE  (bupropion SR/naltrexone SR) in the treatment of obesity.

Some may think that a positive recommendation for a diet drug is overdue from this Committee because they have already failed to recommend approval for two other diet drugs just this year.  Those who think that way are mistaken.  We think this Advisory Committee is tuned in to the same wave length as the FDA on these drugs. They will see this as another fixed combination diet drug and look for a positive benefit risk ratio. We don’t think they’ll find one.