Contrave by Orexigen could come in the market

Orexigen Therapeutics Inc. has reported on Monday that it has reached at an agreement with U.S. regulatory officials i.e. Food and Drug Administration (FDA) for placebo-controlled trials.

"We are pleased to receive agreement on the SPA (Special Protocol Assessment) from the FDA after just one cycle of review," said Michael Narachi, President and CEO of Orexigen. "A few months ago, we received detailed written correspondence from the FDA's Director of the Office of New Drugs that identified a clear and feasible path forward for this important potential obesity therapy. We believe the rapid progress we have since made with the FDA's Division of Metabolic and Endocrinologic Products on the detailed protocol and plans for analysis is further indication of the alignment we have reached within the FDA on the requirements for resubmission of the Contrave NDA."

Orexigen will work with Takeda Pharmaceuticals Co. to work on the introduction of drug in U.S., Canada and Mexico.

Source:
SayPeople

Via:
Orexigen