Experimental drug Contrave(R) (naltrexone SR/bupropion SR) for the treatment of obesity has been recommended for approval by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee. The Committee (Panel) voted 13 to 7 in favor of approving Contrave for long-term use among certain obese and overweight patients.

The Panel’s recommendation is not binding for the FDA (Food and Drug Administration) when it makes its final NDA (New Drug Application) decision. However, it usually goes along with what the Panel advises.

Michael Narachi, president and CEO of Orexigen, said:

    “We are encouraged by the panel’s view of the risk-benefit profile of Contrave. We look forward to continued discussions with the FDA regarding the design of a post-marketing study to evaluate cardiovascular risk and to address the questions raised at the meeting today in preparation for our PDUFA action date in January.”

Shinji Honda, president and CEO of Takeda Pharmaceuticals North America, Inc., a wholly-owned subsidiary of Takeda, said:

    “We are pleased with today’s committee vote, an important step on the path to approval for this potential new option for the treatment of obesity and an example of the dedication of the Orexigen-Takeda team. Takeda is committed to working to provide new treatment options in managing obesity and helping physicians address this growing epidemic. We believe Contrave, if approved, could be an important addition to the limited therapeutic options currently available.”

Contrave is an experimental medication for the treatment of obesity. It has two components – naltrexone SR and bupropion SR – which appear to act in the central nervous system in a complementary manner, addressing both behavioral and biological drivers of obesity, according to the company Orexigen. They are said to influence appetite and cravings. Bupropion is an antidepressant used in smoking cessation, while Naltrexone is used for alcohol and painkiller addiction treatment.

Market experts say Orexigen, the makers of Contrave, benefitted from earlier problems encountered by its rivals – getting an obesity drug onto the market has been fraught with safety problems and rejections. The company’s shares more than doubled today after news came through regarding the Panel’s recommendation.

The Panel said the benefits of Contrave far outweigh the two main adverse effects; elevated heart rate and hypertension. They also agreed that a large study on cardiovascular risk does not need to occur before approving the drug (it can happen afterwards).

Approximately 68% of US adults are obese/overweight – almost 34% are obese. Obese individuals have a much higher risk of developing hypertension (high blood pressure), several cancers, heart disease and diabetes.

Orexigen and its partner Takeda Pharmaceutical Co. expect to receive an FDA decision at the end of January, 2011.

A 56-week trial revealed that twice as many participants on Contrave lost 5% of their body weight, compared to those on a placebo.

Sources: Takeda, Orexigen, and the FDA

Written by Christian Nordqvist