The FDA approves the first pill specifically intended to treat postpartum depression – Gist It

The FDA approves the first pill specifically intended to treat postpartum depression

The FDA has approved the first pill, “Zurzuvae”, specifically intended for treating severe postpartum depression in adults.

Approval Breakdown: The pill is administered once a day for a period of 14 days.
* Dr. Tiffany Farchione, FDA’s director of psychiatric drugs, expressed the importance of an oral medication for women dealing with extreme feelings related to postpartum depression.
* The pill was developed by Sage Therapeutics, which also offers an intravenous drug given over three days in a medical facility, approved by the FDA in 2019.

By the Numbers: Postpartum depression affects an estimated 400,000 people annually.
* Standard treatment includes counseling or antidepressants, which may not work rapidly or help everyone.

Data Behind Approval: The approval was based on two company studies demonstrating that recipients of Zurzuvae experienced reduced signs of depression over a 4 to 6 week period compared to those given a placebo.
* Benefits were seen as early as within three days for many participants.

Patient testimony: Sahar McMahon, a New York City resident and mother, participated in the drug study and reported marked improvement in her depressive symptoms within days of commencing medication.

What Professionals Say: Dr. Kimberly Yonkers of Yale University gave a positive review of the drugs effects but suggested more follow-up data on post-treatment outcomes should have been required. She raised concerns about the unknowns surrounding the patients’ conditions after 45 days of treatment.

Side Effects and Future Considerations: Side effects include drowsiness and dizziness. The market price of Zurzuvae is yet to be announced, but this factor will heavily influence its prescription frequency.

View original article on NPR

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August 5, 2023

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