Sage Therapeutics Wins FDA Approval of Drug for Postpartum Depression

Sage Therapeutics, a biopharmaceutical company developing novel medicines to treat life-altering central nervous system disorders, has announced that the FDA has approved Zulresso^TM (brexanolone) injection for the treatment of postpartum depression (PPD). Zulresso is the first and only medicine specifically approved to treat PPD, the most common medical complication of childbirth. Zulresso is expected to be available in late June.

PPD can affect women during pregnancy or after childbirth. It is estimated PPD affects approximately one in nine women who have given birth in the U.S. Symptoms 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. Without proper screening, up to half of PPD cases may go undiagnosed.

Zulresso was evaluated by the FDA under Priority Review, which is reserved for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition. In 2016, Zulresso was also granted Breakthrough Therapy Designation status, underscoring the significant unmet need in women with PPD.

“We are proud to be a part of this important moment in mental health, creating the opportunity for an unprecedented change in the way postpartum depression is thought about and treated moving forward,” said Jeff Jonas, M.D., chief executive officer of Sage. “…We believe Zulresso will be a catalyst in starting a new dialogue emphasizing the importance of women’s mental health, and the importance of diagnosing and treating PPD.”

Zulresso is an allosteric modulator of both synaptic and extrasynaptic GABA_A receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor. Zulresso is approved by the FDA for the treatment of PPD in adults, pending DEA scheduling and has also been granted PRIority MEdicines (PRIME) designation from the European Medicines Agency. (Source: Sage Therapeutics Website, 19 March, 2019)