Orexigen and FDA find way forward for obesity drug Contrave

Shares of US drug developer Orexigen Therapeutics (Nasdaq: OREX) 86% to $2.74 in extended trading yesterday, after the company said that a recent meeting with senior officials in Food and Drug Administration's Office of New Drugs (OND) had resulted in establishing a pathway to resubmission of the New Drug Application for its obesity drug candidate Contrave (bupropion/naltrexone).

The move bodes well for the weight-loss drug market - where no new prescription medicine has been cleared by the FDA since 1999 - and follows the news last week that fellow obesity drug developer Vivus has also found a way forward for its candidate Qnexa (phentermine/topiramate (The Pharma Letter September 16).

Orexigen received written correspondence detailing the OND's design requirements for a cardiovascular outcomes trial (CVOT) for Contrave that would address the Complete Response Letter (CRL) received in January and the company put a hold on development of Contrave in the summer due to “unprecedented” demands from the FDA (TPL June 6). Orexigen believes that these design requirements are reasonable and feasible and provide the certainty required to reinitiate development of Contrave.