US Approves First Oral Pill for Postpartum Depression.
The Food and Drug Administration (FDA) has granted approval for the first-ever oral pill, Zurzuvae, to treat postpartum depression (PPD). Developed by drug manufacturers Sage Therapeutics and Biogen, the once-daily pill will be available for a two-week treatment regimen. This groundbreaking approval marks a significant advancement in PPD treatment, as until now, options were limited to intravenous injections.
PPD is a serious condition affecting many women, with symptoms including sadness, loss of energy, cognitive impairment, and even thoughts of self-harm. Studies estimate that around one in seven women in the US experience PPD symptoms.
Tiffany Farchione, the head of psychiatry in the FDA’s Center for Drug Evaluation and Research, emphasized the importance of effective treatment for PPD, as it can disrupt the crucial maternal-infant bond, impacting the child’s emotional and physical development.
Clinical trials demonstrated that Zurzuvae substantially reduced depressive symptoms within just three days, and its effects were maintained up to four weeks after the last dose. The medication has some common side-effects, such as drowsiness, dizziness, and fatigue, among others.
To ensure safety, the drug comes with a boxed warning, indicating that it may affect a person’s ability to drive and perform hazardous activities. As a precaution, patients are advised not to drive or operate heavy machinery for at least 12 hours after taking the medication.
While the approval for PPD treatment is a significant achievement, Sage Therapeutics and Biogen had also sought approval to use zuranolone for major depressive disorder (MDD). However, the FDA determined that the evidence of effectiveness for MDD treatment was not substantial enough, and additional studies would be required.
The drug manufacturers expressed disappointment in this decision, particularly during the ongoing mental health crisis when millions of people with MDD are seeking relief. They are currently evaluating their next steps to address this issue. Nevertheless, the approval of Zurzuvae as an oral option for postpartum depression represents a critical step forward in providing relief to women coping with this challenging condition.
