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. The study a double-blind, placebo-controlled CV outcomes trial that randomized approximately 8,900 patients.
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 CV 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.
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.
If Contrave is approved, partner Takeda will launch the product in the U.S.