Vivus agrees pathway with US FDA for re-submission of Qnexa NDA

There was a shot in the arm for US drug developer Vivus (Nasdaq: VVUS) yesterday, when the company said that, following a recent teleconference, it has reached agreement with officials of the US Food and Drug Administration’s Endocrine and Metabolic Division on a plan that allows for an early resubmission of the Qnexa (phentermine/topiramate), New Drug Application for the treatment of obesity. Vivus saw its shares gain 6.8% to $9.05 in pre-market trading yesterday, but leveling off at $8.00, up 4.8% by close.

Vivus, like other companies hoping to bring a new obesity drug to the market, has experienced difficulties, and earlier this year the FDA raised questions about birth defects and cardiac effects in relation to the use of one of Qnexa’s ingredients, topiramate (The Pharma Letter January 24).

The agency has not approved a new drug for obesity/weight control since 1999, and the likes of Orexigen Pharmaceuticals’ Contrave (naltrexone sustained release (SR)/bupropion SR) and Arena Pharmaceuticals’ lorcaserin are still under review by the agency, although Orexigen has put a hold on its obesity program, citing “unprecedented” demands from the agency (TPL June 6). Interestingly, the Vivus news pushed the latter’s shares up 14.9% and Arena rose 6.5%.