Zurzuvae: Until now treatment for postpartum depression was available only as an intravenous injection, the FDA noted.
The US Food and Drug Administration (FDA) approved Biogen and Sage Therapeutics’ oral pill to treat postpartum depression (PPD). The companies had sought approval for the drug named Zurzuvae. The drug treats major depressive disorder (MDD) or clinical depression as well as postpartum depression. PPD severely affects a woman’s ability to return to normal functioning after pregnancy. It can also potentially affect the mother’s relationship with her newborn child.
“Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which is anticipated to occur within 90 days,” Sage Therapeutics and Biogen said in a statement.
What FDA said about Zurzuvae?
The FDA issued a Complete Response Letter for the New Drug Application for Zurzuvae in the treatment of adults with MDD, the statement said adding that the application did not provide substantial evidence of the effectiveness of Zurzuvae for treating of MDD. Additional studies would be needed to support the approval, the agency said. Sage and Biogen said that they were reviewing the feedback and evaluating next steps.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” Dr. Tiffany Farchione, FDA’s director of psychiatric drugs, said in a statement.