Published: Sat, March 23, 2019
Medical | By Mark Scott

United States approves first treatment for post-partum depression

United States approves first treatment for post-partum depression

The FDA approved Zulresso, the first treatment specifically intended for women with postpartum depression.

The FDA on Tuesday approved intravenous infusion of the drug brexanolone, which will be sold as Zulresso.

"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 drug is administered as a continuous I.V. infusion over 60 hours.

Zulresso was approved with Risk Evaluation and Mitigation Strategy and is only available to patients through a restricted distribution program at certified health care facilities. "She noted that postpartum depression, one of the most common complications of childbirth, is 'underdiagnosed and neglected, ' and that suicide is a major cause of maternal death", Laurie McGinley and Lenny Bernstein report for the Washington Post.

Sage submitted its New Drug Application in May 2018 based on data from two Phase III clinical trials in patients with severe postpartum depression and moderate postpartum depression. Would this new drug to treat postpartum depression have helped?

Sage Therapeutics told the Times that insurance companies are now evaluating Zulresso, and the company expects insurers will cover the treatment. The medication will be available in June. Some woman can be so affected by the issue they can have thoughts of harming themselves or their child, Farchione said.

The treatment's 60-hour length could make it hard for some new mothers to be able to participate ― after all, it involves sedation, and patients must be accompanied when interacting with their children during the infusion, according to the release.

This is much quicker than the antidepressants now used to treat postpartum depression, which take anywhere between two to four weeks to take effect. Symptoms were improved at the end of the first infusion, and Zulresso remained effective through to a 30-day follow up.

The treatment is also expensive; it can cost between $20,000 and $35,000, not including the cost of the hospital stay. The results of early clinical studies, which were released January 2019, suggest that the medication also has the potential to quickly and significantly reduce depressive symptoms in women with PPD.

That being said, this new treatment may be a good option for those who experience more severe PPD and have failed to respond to SSRIs, she added. "Still, the results were considered persuasive by a joint FDA advisory committee a year ago, which recommended approval in near-unanimous votes", the NYT's Belluck reports.

Estimates indicate that each year, more than 400,000 infants in the United States are born to mothers who are depressed, CNN reported. Cloonan says the company is now navigating coverage options. UNC School of Medicine (SOM) researcher Samantha Meltzer-Brody, MD, MPH, was the academic principal investigator of the trials, and says this approval could change the way postpartum depression is treated.

Srinivasan also raised concerns about the drug's side effects, which can include sleepiness, dry mouth and loss of consciousness.

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