Interim analysis of Orexigen Therapeutics’ experimental weight loss drug Contrave showed successful results, setting the stage for possible marketing approval by United States drug regulators by June 2014.
The Food and Drug Administration (FDA) rejected Orexigen’s bid for approval in February 2011, saying it needed more data from a large-scale study on the long-term effects the obesity medication has on the heart.
Contrave is a combination of two already approved medications – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in in order to decrease food intake over an extended period of time.
Orexigen is eager to jump into the diet drug market. Only two drugs have been approved by the FDA to treat obesity in recent years – Vivus Inc.’s Qsymia and Arena Pharmaceuticals Belviq. Both drugs were initially rejected based on cancer and cardiovascular risks. The agency requested more data from clinical trials before approval was granted. The drugs were the first prescription diet pills to win FDA approval in 13 years.
The FDA has previously said that Contrave could be approved if interim analysis meets specified criteria regarding cardiovascular risk. Orexigen it will resubmit its New Drug Application to the FDA within weeks, with hopes of a decision on approval by June 2014.
In October, Orexigen submitted a Marketing Authorization Application for Contrave with the European Medicines Agency.
Source: RTT News