AV-101 Phase 2b Study for Adjunctive Treatment of MDD
We are currently preparing to launch a Phase 2b clinical study of AV-101 for the adjunctive treatment of MDD in patients with inadequate response to standard FDA-approved antidepressants. We anticipate the launch of this multi-center, multi-dose, double-blind, placebo-controlled Phase 2b efficacy and safety study, which is expected to enroll approximately 280 patients, in the first half of 2017. Topline clinical results from this study are expected by the end of 2018. The Principal Investigator of the study will be Dr. Maurizio Fava of Harvard Medical School. Dr. Fava was the co-Principal Investigator with Dr. A. John Rush of the largest clinical trial ever conducted in depression, STAR*D, whose findings were published in journals such the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA).