USFDA approves first drug for postpartum depression | #115915

The drug named Zulresso needs to be administered intravenously in a hospital over the course of 60 hours. — AFP  File

Treatment is likely to cost around 20,000 to 35000 dollars. But for others, those treatments are slow to provide relief. Postpartum depression or "baby blues" commonly occurs just before and right after childbirth and can be severely debilitating to the mother.

For the first time in history, the US Food and Drug Administration approved a drug for the treatment of postpartum depression, which experts said could be life changing for new mothers.

The drug's approval "represents a game-changing approach to treating PPD", said Samantha Meltzer Brody, Ray M Hayworth Distinguished Professorship of Mood and Anxiety Disorders and director of the Perinatal Psychiatry Program, UNC Center for Women's Mood Disorders and primary investigator of the Zulresso clinical trials. A unique dose group of ZULRESSO 60 μg/kg/hr in one of the studies was not included in the integrated efficacy analysis, but was included in integrated analyses of safety.

The trials studied 247 women who were randomly selected to receive either brexanolone or a placebo. It often ends naturally within a couple of weeks, but for some, it can also continue for months and even years. The drug is instead administered intravenously during a 60-hour infusion at a medically supervised setting, like a hospital.

"The side effects are certainly things that need to be monitored and observed", Meltzer-Brody acknowledged. "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 those patients that experienced loss of consciousness, this resolved within 15 minutes, and all excessive sedation events were completely resolved within 90 minutes", she said. So far, though, it looks like only small amounts of the medication reach the breast milk.

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Up until Zulresso was approved, typical treatment options for PPD have been antidepressants. "Many women experience great shame and feel inadequate as mothers if they struggle with depression at a time that is supposed to be joyous".

But Zulresso won't be cheap.

Zulresso might cost up to $34,000 per patient, excluding the costs associated with several days stay in a medical center. The infusion helps to restore the normal levels of the hormone and emotions as well. "We're talking about a single treatment that has durable effects", explained Dr. Kanes.

Brexanolone, which is a synthetic compound made from progesterone, acts to correct the hyperactive GABA receptors and, ultimately, reduce depressive symptoms, said Gaither.

The drug is called brexanolone - brand name Zulresso - and needs to be given in a healthcare facility under medical supervision.

"Overall, at 60 hours, about 75% of women who received brexanolone were at least 50% improved in their symptoms and about half of women who received brexanolone were no longer clinically depressed", a researcher involved in two of the drug's clinical trials tells Howard.

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