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FDA gave nod for Zurzuvae to treat postpartum depression but NO to major depressive disorder

Zurzuvae (zuranolone) received FDA's nod for postpartum depression (PPD) in adults. PPD, characterized by a major depressive episode occurring typically after childbirth and sometimes during late-stage pregnancy, has conventionally been treated through intravenous (IV) injections administered by healthcare providers in specific healthcare facilities.


Clinical trials evaluating Zurzuvae's efficacy for treating PPD involved two randomized, double-blind, placebo-controlled, multicenter studies. These studies included women diagnosed with PPD who have a major depressive episode, with symptom onset during the third trimester of pregnancy or within four weeks following delivery.


In Study 1, participants received a once-daily 50 mg dosage of Zurzuvae or placebo over 14 days. Study 2 involved a comparable product, similar to 40 mg of Zurzuvae, administered over 14 days. Participants were closely monitored for at least four weeks after the treatment period. The primary evaluation criterion for both studies was the alteration in depressive symptoms, as measured by the total score from the 17-item Hamilton depression rating scale (HAMD-17) on day 15.


Notably, individuals in the Zurzuvae groups displayed a substantial reduction in symptom severity compared to those in the placebo groups. This favourable treatment effect persisted even at Day 42, four weeks after the final dose of Zurzuvae.


Postpartum depression is a significant concern during and after pregnancy, with mental health conditions constituting a leading cause of maternal mortality. Approximately one in every eight women experience PPD symptoms, a substantial proportion of which might go undiagnosed due to inadequate screening. The research underscores that merely 15.8% of women manifesting PPD symptoms seek treatment. These symptoms can extend beyond the postpartum period, potentially leading to prolonged maternal morbidity. Indications of PPD encompass a depressed mood, loss of interest in activities, changes in sleep patterns and appetite, diminished energy, feelings of guilt or insignificance, impaired concentration, and, in some instances, suicidal thoughts.


For patients considering Zurzuvae, the recommended daily dosage is 50mg, to be taken once a day for 14 days. Consumption should occur during the evening alongside a fatty meal.


Furthermore, the FDA has issued a Complete Response Letter (CRL) for zuranolone's NDA application for major depressive disorder (MDD) among adults. The CRL outlined that the application lacked significant evidence of efficacy required to endorse zuranolone for MDD treatment. As a result, the FDA has indicated the necessity for additional study or studies to substantiate its potential. Sage and Biogen are actively engaged in an assessment of the feedback received and are currently in the process of deliberating on the subsequent course of action.

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