Orexigen Therapeutics, Inc. said Tuesday that the Food and Drug Administration has agreed to a study to revive the company's previously-rejected weight loss drug Contrave.
"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 statement.
The FDA rejected Contrave in February due to the risk of heart problems, but stated in a press release Tuesday that "if the interim analysis meets the specified criteria to exclude an unacceptable increased cardiovascular (CV) risk, the drug could be approved."
The proposed study would involve 10,000 patients and take two years to gather data on heart side effects, according to Orexigen. The FDA rejected two other experimental weight loss drugs earlier this year, according to The Associated Press. Abbott Laboratories' Meridia, was taken off the market in October after research showed it increased the risk of heart attack and stroke.
Contrave is combination of an antidepressant and an anti-addiction drug to curb appetite. Four out of 10 patients lost at least 5 percent of their body weight after taking Contrave for a year. "I think this was a multi-pronged effort that we built to create some momentum that helped the process," Narachi said Tuesday in a conference call with the AP.