Orexigen says FDA may allow faster resubmission for diet pill
(Reuters) – Orexigen Inc said the U.S. health regulator indicated it would be willing to discuss a faster resubmission of the company’s application to market its weight loss pill Contrave.
The U.S. Food and Drug Administration in January 2011 decided against approving Contrave, citing possible heart problems, and requested an additional trial to establish safety.
Orexigen said on Monday it plans to explore with the FDA the possibility of resubmitting the application in advance of the interim data from its additional study.
The company also said it had enrolled 7,000 patients in the study and plans to enroll nearly 9,000 by the end of the year.
The faster-than-expected enrollment and the update from the FDA’s Center for Drug Evaluation and Research could reduce the time for potential approval of Contrave, the company said.
(Reporting by Vidya P L Nathan,)