Waiting Waiting

Orexigen: Hurry Up and Wait

Orexigen and the rest of the world have been poised for action by the FDA today to approve the drug formerly known as Contrave, a combination of bupropion and naltrexone, for the treatment of obesity. Today, June 11, was the date that FDA was required to render judgement on their resubmitted application, based upon new safety data submitted at the end of last year.

Alas, we will hall have to wait another three months. The new date will be September 11, coincidentally also the date for an FDA advisory committee hearing on Novo Nordisk’s application to market liraglutide for obesity. Two bits of news can be taken from this announcement:

  1. FDA and Orexigen could not get the job done in time. It’s apparent the the company and the agency are still working out the details of labeling and post-marketing commitments. As badly as Orexigen wants to get on with it, some details remain to be settled. The company’s stock price took a 15% hit when the news was announced this morning. Investors don’t like surprises.
     
  2. The Contrave name is history. In the company’s press release, they are now referring to the product as NB32. This would seem to confirm reports that FDA has taken issue with the name that Orexigen chose for their product. FDA approval or rejection of brand names is a bit of an erratic process. To maximize their leverage, the agency often will reject a trade name at the last minute, leaving companies with little room to negotiate if they want to launch in a timely fashion.

 
While this is not good news, it’s not particularly bad news, either. It’s just a frustrating delay.

Click here to read the press release and here to read more about the product.

Waiting Waiting, Photograph © Brett Davies / flickr

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