San Diego-based Orexigen Therapeutics Inc. (Nasdaq: OREX) announced Tuesday it has received word that the U.S. Food and Drug Administration considers the recent resubmission of its Contrave new drug application to be a complete response to the FDA's action letter from Jan. 31, 2011.
The acceptance of Orexigen's resubmission paves a way forward for a commercial launch of Contrave, an investigational medication being evaluated for weight loss and weight loss maintenance.
For the resubmission, the FDA has assigned a Prescription Drug User Fee Act goal date of June 10. If approved, Orexigen expects commercial launch of Contrave by North American partner Takeda Pharmaceuticals in the second half of the year.
"We will continue to work closely with the FDA during the review of the Contrave NDA resubmission, and, if approved, we and Takeda look forward to making Contrave available to patients soon thereafter," said Michael Narachi, CEO of Orexigen.
Orexigen resubmitted the Contrave NDA in December 2013 following the earlier announcement of the successful interim analysis of the Light Study, the Contrave cardiovascular outcomes trial.
The study was a double-blind, placebo-controlled cardiovascular outcomes trial that randomized approximately 8,900 patients. Orexigen announced successful results of the interim analysis in November, stating that it met the prespecified criteria.