Orexigen Therapeutics Inc., biopharmaceutical company, has announced on Monday that it has reached at an agreement with the U.S. Food and Drug Administration (FDA) on the details of design and analysis of its experimental diet and obesity drug Contrave (naltrexone SR/bupropion SR).
“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.”
The company is going to work with Takeda Pharmaceutical Co. to develop and introduce the drug in U.S., Canada and Mexico.
The company has planned to enroll 10,000 patients in the placebo-controlled trial in order to prove that the drug has no risks of unacceptably increasing adverse cardiovascular events.
More details of the trial design and protocol will be revealed on the fourth-quarter of the company.