SAN DIEGO, Aug. 27, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the Light Study independent Data Monitoring Committee has recently confirmed that sufficient major adverse cardiovascular events (MACE) are expected to occur within the next two months, enabling the interim analysis to be conducted by early December and the potential resubmission of the Contrave® New Drug Application (NDA) by year end. The DMC also recommended that the Light Study continue as planned with no changes to the protocol.
"I'm proud of the progress made by our Light Study team," said Michael Narachi, Chief Executive Officer of Orexigen. "We remain focused on trial execution and launch preparation and look forward to the interim analysis and upcoming regulatory submissions."
Orexigen also today reiterated its plan to submit a Marketing Authorization Application (MAA) for Contrave® to the European Medicines Agency (EMA) in advance of the Light Study interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions.
About Contrave (32 mg naltrexone sustained‐release (SR)/360 mg bupropion SR) for the treatment of obesity: In 2012, Orexigen screened more than 13,000 patients, enrolled more than 10,400 and ultimately completed recruitment of the Light Study with approximately 8,900 randomized patients. The primary objective of the double‐blind, randomized, placebo‐controlled Light Study, which Orexigen is conducting under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave.
|SOURCE Orexigen Therapeutics, Inc.|
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