The US Food and Drug Administration has said it is “disappointed” by Orexigen Therapeutics’ (Nasdaq: OREX) decision to disclose interim data showing its obesity treatment Contrave (bupropion/naltrexone) reduces the risk of cardiovascular events.
The company’s shares jumped as much as 58% on Tuesday as it revealed results from the LIGHT trial of Contrave, but the FDA had already asked Orexigen to conduct a second study in order to prove the medicine is safe for the heart.
This study looked at 9,000 obese patients, and participants who received the drug had a 41% lower risk of a heart attack and stroke than those in the placebo arm.
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