Illustration: Eniola Odetunde/Axios
The first pill for postpartum depression was approved by the FDA on Friday.
Why it matters: Depression is one of the most common medical complications during and after pregnancy.
- Postpartum depression, which is experienced by about 1 in 8 people after a recent birth, is associated with poor maternal and infant health outcomes.
How it works: The drug, zuranolone, is taken daily for two weeks.
- In a trial, treatment "led to rapid and nominally significant improvements in depressive symptoms versus placebo."
- Anxiety and global functioning symptoms also improved.
- The drug can also be used to treat major depression order, Biogen said.
Between the lines: The study period lasted 45 days, but researchers are not aware of how long the treatment is sustainable beyond this point.
- Patients were not permitted to breastfeed during the treatment period and for one week after it ended, safety of breastfeeding on the medication is also unknown, researchers said.
Details: Biogen, a biotechnology company, and Sage Therapeutics, a biopharmaceutical company, collaborated to develop and commercialize zuranolone.
- The companies said the FDA granted priority review to their application with an action date of Aug. 5.
- In 2019, Sage Therapeutics failed a late-stage study on an experimental drug intended to treat severe depression.
What they're saying: "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 Farchione, director of the psychiatry division in the FDA's Center for Drug Evaluation and Research, said in a statement.
Flashback: The FDA approved the first drug, also developed by Sage, for postpartum depression in 2019, administered as a continuous IV infusion.
- This treatment takes more than 60 hours.
Of note: According to the Mayo Clinic, postpartum depression symptoms may include:
- Depressed mood or severe mood swings
- Difficulty bonding with baby
- Withdrawing from family and friends
- Overwhelming tiredness or loss of energy
- Less interest and pleasure in activities you used to enjoy
- Feelings of worthlessness, shame, guilt or inadequacy
- Reduced ability to think clearly, concentrate or make decisions
Go deeper: 12,000 people used a national maternal mental health hotline in its first year
Editor's note: This story has been updated to reflect the FDA's approval.