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.
Read more: Beijing airs documentary showing China army's prep for Taiwan attack: Report
“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.
{{/usCountry}}“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.
{{/usCountry}}Until now treatment for postpartum depression was available only as an intravenous injection, the FDA noted.
How many people are affected by the disorder?
In 2021, an estimated 21 million adults in the US had at least one episode of major depressive disorder. PPD affects around one in seven women who give birth. Although, it often ends on its own within a couple weeks, it can continue for months or even years. Treatment usually includes counseling or antidepressants, which can take weeks to work.