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Report: Orexigen Therapeutics Jumped Gun On Contrave Heart Study


Orexigen Therapeutics, Inc. (NASDAQ: OREX) may have jumped the gun in reporting that its anti-obesity drug Contrave offers unexpected benefits to cardiovascular patients.

The Miami-based company gained more than 30 percent on the news Tuesday, but the disclosure moved the Food and Drug Administration to request that Orexigen run a second cardiovascular outcomes trial, according to Bloomberg.

The current Phase III study was launched in 2012 and is expected to be completed in 2017.

Regulators are concerned that participants in the study who are receiving a placebo may learn of the outcome and thus invalidate results.

Further study may delay any potential approval of Contrave for cardiovascular patients. Contrave received marketing clearance as an obesity treatment last year.

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The current Phase III study was launched in 2012 and is expected to be completed in 2017.

Steve Nissen, the trial's lead investigator at the Cleveland Clinic, told Bloomberg that public disclosure of the incomplete data was "strictly forbidden by the agreement."

The Food and Drug Administration said it's "very disappointed in Orexigen" according to Forbes, which apparently broke the story earlier Tuesday.

News slipped out, according to Orexigen, when its patent application was made public by the U.S. Patent Office Tuesday.

The application contains claims related to an "unexpected positive effect" of the drug on cardiovascular patient outcomes independent of weight change, the company said.

The effect of Contrave on cardiovascular morbidity and mortality hasn't been established, Orexigen added.


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