In the latest episode in the long-running saga to get a new weight loss drug onto the US market, Orexigen Therapeutics has reached agreement with the Food and Drug Administration on the design of a cardiovascular outcomes trial required for its obesity drug Contrave.
Just over a year ago, the company's New Drug Application for Contrave (naltrexone/bupropion) was rejected by the FDA over "a single approval deficiency related to cardiovascular safety". The outcomes trial, which will be conducted under a special protocol assessment designed with the agency, will begin late in the second quarter of 2012 and enrol 10,000 patients.
Michael Narachi, Orexigen's chief executive, said the talks with the FDA have "identified a clear and feasible path forward" for the drug, which is partnered with Japan's Takeda.
Contrave is one of three obesity treatments the FDA has rejected over safety concerns. The other two, Arena Pharmaceuticals/Eisai's lorcaserin and Vivus' Qnexa (phentermine/topiramate) have both been recently resubmitted to the agency.