The
"The FDA approval of Zurzuvae to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition," commented
Based on clinical data, this treatment option has potential to provide “rapid improvements in depressive symptoms in as early as three days for women with postpartum depression," explained Dr
FDA approval of Zurzuvae for postpartum depression was granted to
Evidence of efficacy for postpartum depression
Basis of the FDA approval
The
Postpartum depression patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to given a placebo treatment. The treatment effect was maintained at Day 42—four weeks after the last dose of Zurzuvae.
In the SKYLARK study, part of the NEST clinical development programme evaluating Zurzuvae for postpartum depression, data showed a significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45.
FDA complete response letter for MDD
Additionally, the FDA has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Zuranolone as a treatment of adults with major depressive disorder (MDD). The letter stated that the application did not provide substantial evidence of effectiveness to support the FDA approval of Zuranolone for treating MDD; additional study or studies will be needed.
Along with
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