Posted by If approved, ZULRESSO would be the first medicine specifically indicated for the treatment of postpartum depression (PPD)
Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, announced that the U.S. Food and Drug Administration (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™ (SBECD enabled brexanolone) injection for the treatment of postpartum depression (PPD). The committees based their joint recommendation on the safety and efficacy data from three placebo-controlled clinical studies.
ZULRESSO is the first medicine under FDA review specifically for the treatment of PPD, the most common medical complication of childbirth.
About Postpartum Depression
Postpartum depression (PPD) is a distinct and readily identified major depressive disorder that is the most common medical complication of childbirth, affecting a subset of women typically commencing in the third trimester of pregnancy or within four weeks after giving birth. PPD may have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. Suicide is the leading cause of maternal death following childbirth. Postpartum depression is estimated to affect approximately one in nine women who have given birth in the U.S. and 400,000 women annually. More than half of these cases may go undiagnosed without proper screening. There are no FDA approved therapies specifically indicated for PPD and there is a high unmet medical need for improved pharmacological therapy in PPD.
About ZULRESSOTM (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. ZULRESSOTM (brexanolone) injection has completed Phase 3 clinical development for postpartum depression and a New Drug Application is currently under review with the U.S. Food and Drug Administration. 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.