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GUIDELINES/RECOMMENDATIONS A New Chapter in Postpartum Depression Care: Introduction of an Oral Medication
The FDA’s recent approval of Zurzuvae (zuranolone) marks a significant advancement in the treatment of postpartum depression (PPD) for adults. This first-of-its-kind oral medication, approved through a fast-track designation, offers a new option beyond the previously available intravenous injection, providing a more accessible treatment for women struggling with this serious condition.
Key Points:
- FDA approved zuranolone as the first oral medication for PPD treatment.
- Approval was based on two randomized, double-blind, placebo-controlled, multicenter clinical trials.
- Participants treated with zuranolone showed significant improvement in depressive symptoms, maintained for at least four weeks post-treatment.
- Recommended daily dose is 50-mg, taken once daily for 14 days.
- Boxed warning includes potential effects on driving and hazardous activities, increased risk for at least 12 hours post-dose.
Additional Points:
- Common side effects: drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, urinary tract infections.
- May trigger suicidal thoughts and behavior; potential fetal harm necessitates effective contraception during and 1 week post-treatment.
Conclusion:
- The approval of zuranolone introduces a vital new treatment option for PPD, with demonstrated efficacy and specific considerations for patient safety and convenience.
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“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
Tiffany R. Farchione, MD
FDA Center for Drug Evaluation and Research’s Director of the Division of Psychiatry