The U.S. Food and Drug Administration has approved the very first drug for the treatment of postpartum depression in adult women. This announcement was made on 19 March 2019.
Postpartum depression (PPD) is a mood disorder that women experience after childbirth. Women suffering from PPD have thoughts about harming themselves or about harming their child. They also experience suicidal thoughts.
This new drug is Brexanolone, which is marketed as Zulresso. Brexanolone is available in the form of injection and is manufactured by Sage Therapeutics. This new drug is a form of allopregnanolone, which is a hormone produced by progesterone in the brain.
To study the effects of this drug, two clinical trials were conducted with 246 participants. The first trial consisted of 108 participants, whereas the second trial had 138 participants. All the participants received treatment with placebo and Brexanolone.
Patients receiving Brexanolone as a treatment for postpartum depression showed a drastic improvement as compared to patients receiving placebo. Participants scored their depression before and after receiving treatment. There was a significant decrease in the levels of depression.
There are certain limitations to the use of Brexanolone. Patients may suffer from dizziness and loss of consciousness. Patients are instructed to be monitored for 60 hours after the intake of the medication.
Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research said, “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
Farchione also said, “Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient."
According to the World Health Organization, 22% of new mothers suffer from postpartum depression in India.
Getting approval for this drug is an achievement for women suffering from postpartum depression.