Orexigen’s Contrave Set For FDA Review
This morning, Orexigen Therapeutics announced that FDA has accepted the company’s new drug application for Contrave, an experimental obesity drug. The acceptance means that the company’s application is complete enough to permit a substantive review.
We’ve been covering the three-way race to bring an obesity drug to market. Here are some links to more info about Orexigen and Contrave.
-Contrave is a sustained-release formulation of two drugs already on the market.
-Orexigen recently made corrections to weight loss data it reported from a Phase III clinical trial, making the numbers look a little less rosy but still within FDA’s benchmarks for clinically significant weight loss, the company says.
Still to come: FDA will assign a PDUFA date for Contrave, the goal date for the agency to complete its review of Orexigen’s application. That date should be sometime in 2011.
Orexigen and the other two companies in the obesity drug race, Arena and Vivus, are still looking for partners to bring their obesity drugs to market, should they be approved by FDA. A partnership announcement would be big. It would signal that a large company is ready to put concerns about the drugs’ history of side effects behind them and line up behind a new obesity drug. No news on that front yet, though.