Orexigen Resubmits Contrave New Drug Application
Orexigen Therapeutics has resubmitted the Contrave New Drug Application to FDA. Contrave (naltrexone sustained release (SR) / bupropion SR) is being developed for weight loss and maintenance of weight loss.
The resubmission follows the November 25, 2013 announcement of the successful interim analysis of the Light Study, the Contrave cardiovascular outcomes trial (CVOT), which is being conducted under a Special Protocol Assessment with the FDA. In January 2011, Orexigen received a Complete Response Letter (CRL) from the FDA detailing a single approval deficiency-the need to conduct a clinical trial of sufficient size and duration to exclude excess risk of major adverse cardiovascular events. In less than three years, Orexigen negotiated with FDA a feasible CVOT design, enrolled the CVOT, and generated safety data responsive to the CRL.
"Resubmitting the Contrave NDA is an exciting moment for Orexigen," said Michael Narachi, CEO of Orexigen. "I am proud of our team and admire their determination to bring Contrave forward to help patients with obesity." Narachi continued: "This resubmission sets in motion the first of four potential key catalysts in 2014. With the successful Light Study interim analysis, we are confident in the prospect for approvals next year in the United States and in Europe. If Contrave is approved, we look forward to a well-executed U.S. launch by Takeda. Additionally, we anticipate making progress next year in our discussions with potential partners for Contrave for territories outside North America." By agreement with the FDA, the independent Data Monitoring Committee's summary report of the Light Study interim analysis formed the basis of the resubmission of the NDA. The interim analysis clinical study report (CSR) will be supplied to the FDA within 60 days of the NDA resubmission. The review period for the resubmission is expected to be six months.