FDA approves first medicine for post-partum depression


WEDNESDAY, March 20, 2019 (HealthDay News) - Postpartum depression is a common and often devastating condition for new mothers, but the U.S. Food and Drug Administration on Tuesday approved the first drug to help combat it.

"There are no FDA approved antidepressants for postpartum depression, so approval of the first medication of its kind is a breakthrough for patients", said Dr. Kristina Deligiannidis, who was involved in the trials and is director of Women's Behavioral Health at Zucker Hillside Hospital in NY, according to the TV network.

The treatment is administered as a single 60-hour IV drip and was found to have mild side effects, such as headache, dizziness or excessive sleepiness.

PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy, thought to affect around one in nine women who have given birth in the US.

Health experts believe the new treatment provides hope for the thousands of women who live with PPD each year.

Share on Pinterest The treatment involves an infusion of medication over two days. Getty Images
Share on Pinterest The treatment involves an infusion of medication over two days. Getty Images

Back in 2016, the FDA ordered a "breakthrough therapy designation" for brexanolone, which essentially expedites the development and review of drugs meant to treat a serious or life-threatening condition. The REMS requires that patients be enrolled in the program prior to administration of the drug.

The drug is called brexanolone (its brand name is Zulresso) and it was developed by the Massachusetts-based company Sage Therapeutics.

Sage plans to begin selling the drug in late June, and Zulresso will cost United States dollars 34,000 without insurance. It can be especially devastating because it can cause fear or thoughts of wanting to harm your baby.

Postpartum depression does not go away on its own, if left untreated it can make it very hard for you to get through your day, and can affect your ability to take care of your child or yourself.

It has been shown in clinical trials to work within hours to treat the symptoms of PPD. "Still, the results were considered persuasive by a joint FDA advisory committee previous year, which recommended approval in near-unanimous votes", the NYT's Belluck reports. Many cases of postpartum depression go undiagnosed. After childbirth, "most" new mothers experience a range of symptoms, including mood swings, crying, trouble sleeping and irritability. The Times said that insurers are now assessing the drug. Sage Chief Executive Dr. Jeff Jnas says the infusion helps restore normal levels and emotions. Zulresso will cost about $34,000 per treatment without insurance, plus costs of staying in a hospital or infusion center. There were anecdotal reports of improvements lasting longer than that, but scientists need "more data to understand what happens in a larger population after 30 days", Samantha Meltzer-Brody director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill and principal investigator of the studies, tells Belluck.