Sage Therapeutics got clearance from the FDA for Zulresso (brexanolone) injection for the treatment of postpartum depression (PPD), and is the first and only medicine specifically approved to treat PPD, the most common medical complication of childbirth.
Sage expects to have Zulresso available in late June after scheduling by the U.S. Drug Enforcement Administration.
CNBC news reported that Shares of Sage Therapeutics jumped more than 5 percent after hours Tuesday based on the news from the FDA. Also, Sage’s stock was up more than 60 percent year to date in anticipation of the approval.
Samantha Meltzer Brody, the primary investigator of the Zulresso clinical trials, said: “The potential to rapidly reduce symptoms in this critical disorder is an exciting milestone in women’s mental health. PPD is recognized to have a significant and long-term impact on women and their families, but with Zulresso we may finally have the opportunity to change that.”
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.
contributed by Zlatka M,
edited by Dino Mustafić