Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced progress with the United States Food and Drug Administration (FDA) on a faster path to resubmission of the Contrave® (naltrexone SR / bupropion SR) New Drug Application (NDA).
Consistent with the spirit of the formal dispute resolution request (FDRR) response letter issued to the Company in October by the FDA's Center for Drug Evaluation and Research, the Division of Metabolism and Endocrinology Products (DMEP) has proposed a resubmission procedure that allows the independent Data Monitoring Committee's summary report of the Light Study interim analysis to form the basis of the resubmission of the Contrave NDA. The complete clinical study report (CSR) for the interim analysis, which would ordinarily form the basis for the NDA resubmission filing, would be supplied to the FDA during the review within 60 days of the NDA resubmission.
The Data Monitoring Committee will conduct the interim analysis after at least 87 major adverse cardiovascular events (MACE) are adjudicated in the Light Study. The timing of the interim analysis is dependent upon the rate of MACE in the Light Study. Although the annual MACE rate is still too early to predict, if it is close to the target of 1.5%, Orexigen anticipates conducting the interim analysis and resubmitting the Contrave NDA in the second half of 2013 with potential approval in early 2014.
"We are pleased that our continuing discussions with the FDA have resulted in a proposal by DMEP which expedites resubmission while also allowing the Agency the time it needs to review the Contrave NDA resubmission," said Michael Narachi , CEO of Orexigen.
Orexigen also announced continued preparation for commercialization of Contrave, if approved, with plans to initiate the Ignite Study, a randomized open-label clinical trial designed to provide additional information regarding the real world weight loss potential of Contrave therapy with a commercially available comprehensive lifestyle intervention program versus usual care. Orexigen plans to initiate randomization of approximately 200 patients into the Ignite Study later this quarter.
"2013 promises to be a pivotal year for Orexigen," Narachi continued. "We expect to receive cardiovascular data from the Light Study, to file for approval in the U.S. and Europe, and to provide additional information about Contrave's real world potential with the Ignite Study."
Orexigen Therapeutics, Inc.