Sage Therapeutics released positive top-line results from two Phase 3 clinical trials with its proprietary i.v. formulation of brexanolone; Study 202B in severe postpartum depression (PPD) and Study 202C in moderate PPD. Brexanolone achieved the primary endpoint in both trials. Patients treated with brexanolone demonstrated mean reductions from baseline in HAM-D total scores of 14 to 20 points at 60 hours maintained to 30 days in both trials. The drug was generally well tolerated and showed a similar safety profile as seen in earlier studies.
It is estimated that PPD affects approximately 10 to 20 percent of women giving birth in the U.S. and up to half of these cases may go undiagnosed without proper screening. There are no approved therapies for PPD and there is a clear unmet medical need for treatment.
“Symptoms of PPD should not be overlooked by new moms or those in their support networks and the healthcare community should encourage discussion and appropriate action, said Dr. Samantha Meltzer-Brody, M.D., M.P.H., associate professor and director of UNC Perinatal Psychiatry Program of the UNC Center for Women’s Mood Disorders and primary investigator of the studies. "These data meaningfully advance our understanding of PPD and may prompt medical professionals to evaluate how PPD is perceived, identified and treated within their practices in the future. In these studies, brexanolone provided a profound and durable effect over the study period that could be an important step in potentially changing the way health care providers think about treating this disorder.”
“This is the first Phase 3 program conducted specifically in women with PPD and these results exemplify the value of Sage’s distinct approach to clinical research,” said Jeff Jonas, M.D., CEO of Sage. “We are pleased with the findings, specifically the rapid onset of action and duration of effect observed in all arms of the Hummingbird program. We believe the data represent an unprecedented opportunity in the development of treatments for PPD, and may serve as the catalyst for a paradigm shift in how the disease is approached and, if approved, may change how PPD is treated.”