Orexigen Therapeutics (OREX) is getting an expert panel at the FDA to review its obesity drug Contrave. Long a subject of intense speculation in the blogosphere, the agency says that its advisory panel will sit down to review the drug on December 7, well ahead of its January 31st PDUFA date.
"We look forward to the opportunity to present the findings from the Contrave clinical program and demonstrate the potential value of Contrave in treating patients with obesity," said Michael Narachi, president and CEO of Orexigen. "We believe that weight loss and weight maintenance are achievable goals in the treatment of obesity and its co-morbidities, and that if approved, Contrave will provide physicians and patients an important therapeutic option to address this unmet need."
Orexigen is matched in a hot race with Vivus (VVUS) and Arena Pharmaceuticals (ARNA) to gain an FDA approval for a weight loss drug, a category that has been plagued with a long history of safety issues. In trials Contrave registered a placebo-controlled weight loss of 3.2 percent (in the hard-to-treat diabetic subpopulation) to 5.2 percent in their COR-II study, Arena's drug lorcaserin came in at 3.1 percent to 3.6 percent and Vivus' Qnexa is credited with an 11 percent weight loss at the highest dosage. Arena's panel review is scheduled for September 16.
Each of the developers faces some tough risks in the months ahead. Barron's surveyed a group of analysts recently who felt that Qnexa was an odds-on favorite for approval for a likely blockbuster. But a setback would trigger sharp swings in the stock price. Vivus's review is scheduled for next month.
- check out Orexigen's release
- here's the story from Barron's