Friday, 26 April, 2019

Landmark Drug Treats Postpartum Depression

FDA Approves First Drug Targeted At Treating Postpartum Depression The F.D.A. Just Approved the First Drug for Postpartum Depression
Anna Jefferson | 22 March, 2019, 18:26

Sage Therapeutics notched a pioneering victory on Tuesday when the Food and Drug Administration (FDA) approved its postpartum depression drug 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, a researcher involved in the drug's clinical trials and the director of Women's Behavioral Health at Zucker Hillside Hospital in Manhasset, New York.

Another pill, now involved in clinical trials, has also shown positive results and could be submitted for FDA approval in a couple of years, Sage Therapeutics told The New York Times.

Postpartum depression affects about 400,000 American women a year.

Postpartum depression often occurs following childbirth, but symptoms, including sadness, decreased ability to feel pleasure, cognitive impairment, feelings of worthlessness or suicidal ideation can start during pregnancy, says the FDA.

However, Farchione said Zulresso, also known as brexanolone, will not be available as an over-the-counter prescription right away.

Dr. Tiffany Farchione of FDA's Division of Psychiatry Products said in a statement that postpartum depression is quite a serious condition, which be life-threatening if it goes untreated. "Women may experience thoughts about harming themselves or harming their child, as well as hinder development of a maternal-infant bond", the press release reads.

In the study on new mothers with moderate to severe postpartum depression, Zulresso has been proven to be beneficial.

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Up until Zulresso was approved, typical treatment options for PPD have been antidepressants.

It will be available beginning in June, though administration of the treatment will be restricted to the Zulresso risk evaluation and mitigation strategy program.

For this approval, the manufacturers presented the results of two clinical trials where Zulresso was found to be superior to placebo in improving the symptoms of postpartum depression after the first infusion dose.

Zulresso might cost up to $34,000 per patient, excluding the costs associated with several days stay in a medical center. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale.

Zulresso specifically targets postpartum depression as opposed to other types of depression because it contains a synthetic form of the hormone allopregnanolone, NBC reported.

"Women who had not wanted to eat or interact with others suddenly were smiling, interacting, becoming more social", Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina's Center for Women's Mood Disorders, told CTV News. "There's an enormous need for new, novel ways to treat depression, and to treat it quickly".

However, because of this rare side effect, the FDA has mandated that a boxed warning accompany the drug.

"I think many women who will be on this drug have to realize that they are going to be in a hospital for two-and-a-halfdays straight and be incapacitated", shesaid.

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