FDA announces approval of first postpartum depression drug Zulresso. The US Food and Drug Administration has approved this intravenous infusion of the drug brexanolone, which will be sold as Zulresso for the treatment of postpartum depression.
Shares of Sage Therapeutics rose more than 5 percent after this news. Postpartum depression is known as a major mental illness that affects 1 in 9 mothers during the first months after childbirth.
Zulresso is an IV injection which was found to have mild side effects including dizziness, excessive sleepiness, or headache. According to Sage Therapeutics, the firm that that developed the drug, this treatment requires 60 hours of time and the drug will cost about $20,000 to $35,000 per treatment.
Dr. Jeff Jonas, CEO of Sage Therapeutics said that Zulresso will be available in June and only through a restricted program called the Zulresso Risk Evaluation and Mitigation Strategy (REMS) Program. Two clinical research has shown that Zulresso improved symptoms of the first infusion and reduced their depression scores in women.
Dr. Samantha Meltzer-Brody said, “What has been consistent is that brexanolone had a very robust response — and what’s been most exciting to me, in terms of participating in this new drug development, was the rapid onset of response. The drug works quickly.”
Dr. Samantha is a professor of mood and anxiety disorders at the University of North Carolina School of Medicine in Chapel Hill and a researcher in the rest of the drug.