US FDA tentatively plans December panel review for Contrave anti-obesity agent
This article was originally published in Scrip
The US FDA has tentatively set aside a date in December for its endocrinologic and metabolic drugs advisory committee to review Orexigen Therapeutics' anti-obesity agent, Contrave (naltrexone SR plus bupropion SR).
The tentative date is 7 December, the company said in a statement, which follows acceptance of the NDA by the agency at the beginning of June; confirmation of the date will await publication in the Federal Register. Orexigen stated that the user fee date has been set for 31 January 2011.
There are now three companies very much in a three-way race to gain a share of the US anti-obesity market, and Orexigen will be anxiously watching the outcome of two upcoming panel reviews to learn how panel members view risk-benefit. The endocrine panel is set to review Vivus's anti-obesity drug Qnexa (topiramate plus phentermine) on 15 July, and that agent has a user fee date of 28 October 2010 (scripnews.com, 7 April 2010). Shortly thereafter, on 16 September, the panel is set to review Arena Pharmaceuticals' experimental selective serotonin 2C receptor agonist, lorcaserin, which has a user fee date of 22 October 2010 (scripnews.com, 3 June 2010).
Some have pointed out that, chemically speaking, only lorcaserin is new. And even if the endocrine panel members give the green light for all three experimental agents, the FDA is sure to weigh efficacy and safety very carefully.
Experts in the field say it would be helpful for clinicians to have more options for weight loss, since some agents might work well in some people and not in others.