Orexigen Therapeutics said on Friday that it would explore opportunities for its products outside the United States after failing to sway U.S. regulators from their demands for a heart safety study before approving the company's experimental obesity drug.

The company said, after a recent meeting with the Food and Drug Administration, that the FDA would not consider approving the drug, Contrave, for a narrower population with lower cardiovascular risk without data from the heart outcomes trial.

Orexigen also said its proposed heart study was rejected by the agency.

The FDA rejected Contrave earlier this year, dealing a severe blow to what stood to be the first new diet pill in a decade and crippling Orexigen's shares.

Orexigen said on Friday that it would appeal the latest FDA decisions through a resolution process, saying the agency's request for the heart outcomes trial was "unprecedented and would generate significantly more information than is necessary or feasible."

According to Orexigen, the FDA plans to hold a general advisory committee meeting early next year to discuss cardiovascular assessment for obesity therapeutics.

Meanwhile, Orexigen said it would put on hold any further development for its obesity programs in the United States "until a clear and feasible path to regulatory approval is identified." It will also speed up exploration of opportunities for its product candidates outside the United States.

( Source: Reuters)