Orexigen talks FDA on speeding Contrave review
SAN DIEGO (AP) — Orexigen Therapeutics Inc. said Monday it is in discussions with the Food and Drug Administration about speeding up a regulatory review of Orexigen's obesity drug Contrave.
Shares rose 30 cents, or 4.9 percent, to $6.45 in premarket trading.
Orexigen is looking for ways to quicken the application process for Contrave, and the company said the FDA is open to discussing options. The FDA approved two other obesity treatments in June and July, and Orexigen is looking to get Contrave on the market as soon as possible. The company had said it hoped to file for marketing approval of Contrave in late 2013, and a standard FDA review would take another 10 months.
On Monday Orexigen said it is expanding the study so it can get results faster. It now plans to enroll about 9,000 patients through the end of the year instead of 7,000, saying that could allow it to conduct an interim analysis of the study two months sooner than expected.
Contrave is a pill that combines bupropion, the active ingredient in the antidepressant Wellbutrin, with the anti-addiction drug naltrexone. The FDA refused to approve the drug in February 2011. Since then the agency has approved Vivus Inc.'s drug Qsymia and Arena Pharmaceuticals Inc.'s Belviq, after initially rejecting both drugs.