Orexigen, FDA work out plan for path to approval of obesity drug

FDA requests new clinical trial for Contrave

SAN DIEGO — Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

The drug maker said this week that after meeting with officials from the FDA's Office of New Drugs, it received a list of requirements from the agency about how to design a trial for Contrave (naltrexone and bupropion hydrochloride). The FDA, which declined to approve the drug in January, required that the trial be based on an intent-to-treat analysis, as well as criteria for interpreting the results at interim and final analyses that are similar to those applied to diabetes drugs.

"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," Orexigen president and CEO Michael Narachi said.


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