Sage Therapeutics, a clinical-stage biopharmaceutical company developing medicines to treat life-altering central nervous system (CNS) disorders, announced that the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes, 1 no) that data support the favorable benefit-risk profile of Zulresso (brexanolone) injection for the treatment of postpartum depression (PPD) when administered by qualified staff in a facility that has been certified under a Risk Evaluation and Mitigation Strategies (REMS) program. The committees based their joint recommendation on the safety and efficacy data from three placebo-controlled clinical studies.
“We are pleased the FDA Advisory Committee agreed that the benefit/risk profile of Zulresso supports this novel approach to treating PPD, reflecting the need for an innovative treatment option that may rapidly alleviate suffering for women with PPD and their families,” said Jeff Jonas, M.D., chief executive officer of Sage. “This is another step forward in Sage’s effort to maximize patient benefit by bringing game-changing new treatments to the market.”
Zulresso is the first medicine under FDA review specifically for the treatment of PPD, the most common medical complication of childbirth. It is estimated that PPD affects approximately one in nine women who have given birth in the U.S. and 400,000 women annually. Symptoms of PPD may include sadness, anxiety, irritability, withdrawing from friends or family, having trouble bonding with her baby and thinking about harming herself or, more rarely, her baby.
About Zulresso (brexanolone) Injection
Brexanolone is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor. Zulresso (brexanolone) injection has completed Phase 3 clinical development for postpartum depression and a New Drug Application is currently under review with the FDA. Zulresso for the treatment of PPD has been granted Breakthrough Therapy Designation by the FDA and PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA). The FDA has conditionally accepted the proprietary name Zulresso for Sage’s intravenous formulation of brexanolone.
(Source: Sage Therapeutics)
Filed Under: Drug Discovery and Development
