Orexigen Takes A Red Pen To Contrave Data

The obesity news just keeps coming this week. In a regulatory form filed with the Securities and Exchange commission today, Orexigen Therapeutics made corrections to some of the weight loss data it reported from a Phase III clinical trial of its experimental obesity drug Contrave. The corrections make the numbers look a little less sunny than before. However, the data still meet the FDA's benchmark for clinically significant weight loss, the company writes in the filing. Reading the filing was fascinating for me- in addition to legalese it includes a slideshow presentation for investors. Now, I'm used to seeing slideshows chockablock with structures, but this time there wasn't a single structure to be seen. Bar graphs dominate, with pie charts a close second. The slides have a little bit of everything- much more than just clinical data. There's even a slide (#62, for the curious) that outlines the company's sales strategy with drug reps. Just a few weeks ago Orexigen announced it was filing for FDA approval of Contrave. It's not clear how this adjustment will affect the timeline for the drug's evaluation, if at all. But even if it does lead to some delays, as an analyst reached by BusinessWeek speculates, FDA was already scheduled to finish making decisions on Contrave's two big obesity drug competitors-Arena's lorcaserin and Vivus's Qnexa- first anyway. Orexigen's stock price went down in response to today's news. But in the end what's going to matter is which of the three drugs get approved, and not just their weight-loss effectiveness, but the balance they offer between weight-loss effectiveness and safety. More Reading: WSJ's Health Blog breaks down just what FDA's benchmarks for obesity drugs are:
Under FDA guidelines for clinical trials of obesity treatments, one of two goals must be met. A trial must show that at least 35% of the drug group lost at least 5% of body weight, but that group must be double the percentage of patients with similar weight loss on the placebo. Alternatively, a study can show that patients had an average weight loss that was at least five percentage points higher than the placebo group's loss.

Author: Carmen Drahl

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  1. It also looks like OREX is making up for some of the loss it experienced yesterday. However the stock is also under its 200 day moving average. My guess is that it may trade down or sideways for awhile unless some significant news comes out for the company. With regards to Orexigen’s Contrave, this error in reporting I believe is just a tiny bump, it is unfortunate but the results still look fairly impressive. July 15th and one of Contrave’s Competitors Qnexa is scheduled for a FDA advisory committee review. If Qnexa is given a positive result that day, it may reflect positively onto Contrave/Orexigen and vice versa. More info here: http://www.tesofensine-information.com/contrave.html

  2. Thanks williamt. In my mind there’s an element of trust between consumers, companies, and regulatory agencies around obesity drugs- no one wants another Fen-Phen. We don’t know when Orexigen discovered the error but the fact that they’re reporting it now is good timing, I think. I, too, will be wondering what emerges from the July 15th meeting.

  3. And I hear they are changing the name to Contrive


  1. Orexigen’s Contrave Set For FDA Review | The Haystack - [...] recently made corrections to weight loss data it reported from a Phase III clinical trial, making the numbers look…