Orexigen has another go at FDA approval of obesity drug Contrave

US biopharma company Orexigen Therapeutics (Nasdaq: OREX) is having another stab at gaining approved for its weight-loss investigational drug Contrave (naltrexone sustained release (SR)/bupropion SR), resubmitting a New Drug Application to the US Food and Drug Administration.

Contrave has suffered a number of regulatory hurdles, while rival obesity drugs Vivus’ Qnexa (phentermine/topiramate) and Arena Pharmaceuticals’ Belviq (lorcaserin) were granted FDA approval (though also initially rejected) and are now both on the market.

In January 2011, Orexigen received a Complete Response Letter (CRL) from the FDA detailing a single approval deficiency - the need to conduct a clinical trial of sufficient size and duration to exclude excess risk of major adverse cardiovascular events.