Orexigen Therapeutics (OREX) said Monday that its obesity pill Contrave passed a key heart-safety test, allowing the company to resubmit for U.S. approval "within a few weeks."
If FDA approves Contrave, Orexigen and its marketing partner Takeda will launch the drug commercially in the third quarter of next year. Contrave would be the third obesity pill sold in the U.S., following the disappointing commercial debuts of competing drugs from Vivus (VVUS) and Arena Pharmaceuticals (ARNA).
Orexigen shares rose 16% to $6.67 in early Monday trading.
Obese patients taking Contrave for weight loss were found not be at an increased statistical risk for heart attacks or other heart-related side effects, according to an interim analysis of the "Light" safety study, Orexigen said.The FDA rejected Contrave in 2011 because of concerns that the pill might increase the risk of heart-related side effects. Orexigen conducted the "Light" study in 8,900 obese patients to demonstrate Contrave's safety. No details from the "Light" study were announced Monday except that the drug met the statistical requirements necessary to rule out an increased risk in heart-related side effects. Orexigen did not disclose whether Contrave was associated with a numerical increase in heart-related side effects compared to placebo. Contrave is a single pill containing two already-approved medicines -- naltrexone and bupropion -- which combined are designed to help people lose weight. Contrave is less effective than Vivus' Qsymia but superior to Arena's Belviq, based on their respective phase III clinical studies. The drugs have not been compared directly against each other in any study. In addition to a possible U.S. approval by June 2014, Orexigen believes Contrave could be approved in Europe before the end of 2014. European regulators have already rejected Vivus' and Arena' respective obesity pills.
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