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Del.icio.usShares of Orexigen Therapeutics, Inc. (Nasdaq: OREX) surged more than 80 percent from Tuesday’s closing price in morning trading on Wednesday after the company, along with the U.S. Food and Drug Administration identified “a clear and feasible path to approval for Contrave,” Orexigen’s experimental obesity drug that was shelved earlier this year because of health risks.
“We have been working with clinical experts, advocacy groups, and our partner, Takeda, throughout this process and are pleased with the feedback provided by FDA that identified a very clear and feasible path forward for this important therapy,” said Michael Narachi, President and CEO of Orexigen in a September 21 press release.
Shares of Orexigen touched a high of $2.68, up from Tuesday’s closing price of $1.47, according to Yahoo Finance.
Contrave, an investigational combination therapy of naltrexone HCl and bupropion HCl, was studied for its ability to help people with obesity initiate and sustain weight loss of at least 5 percent of their starting body weight in one year. Contrave was submitted for U.S. regulatory approval in March 2010. The original submission was based on multiple clinical trials that evaluated Contrave in more than 4500 patients.
Orexigen Therapeutics and its Japanese partner Takeda will need to run a patient safety study of approximately 10,000-patients to assess the heart-safety risk of Contrave.
Orexigen estimates that the entire study would require less than 10,000 patients and less than two years from study start to the interim analysis, according to the September 21 press release. Orexigen plans to meet with the review division to finalize a protocol with the objective of initiating the CVOT in the first half of 2012, with potential approval in 2014.
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