Sage Therapeutics gets FDA a wink at Zulresso to treat postpartum depression

Zulresso would be the first and only drug to have obtained the necessary approval to treat PPD, the most common medical complication of childbirth.

The drug is an allosteric modulator of synaptic and extrasynaptic GABA._A receptors. Allosteric modulation of neurotransmitter receptor activity is said to result in a desired degree of activity rather than complete activation or inhibition of the receptor.

The company plans to launch Zulresso at the end of June, after the US Drug Enforcement Administration has scheduled it, which should take place within 90 days.

The FDA has evaluated the new PPD treatment under review priority. In 2016, the company obtained the status of disruptive therapy for Zulresso.

The company has also obtained the priority drug title (PRIME) from the European Medicines Agency (EMA) for Zulresso.

Dr. Jeff Jonas, CEO of Sage Therapeutics, said, "Zulresso will address a significant need for women's mental health, the impact of PLR is multigenerational, and we look forward to bringing ZULRESSO to patients in need. urgent need for a new treatment option. "

The approval is based on data from three placebo-controlled, randomized, randomized, placebo-controlled, placebo-controlled, placebo-controlled trials evaluating the safety and efficacy of Zulresso in women with moderate or severe PAD. at 45 years old.

Patients participating in the trial had at least 6 months postpartum at the time of screening and had no symptoms at the earliest in the third trimester and at the latest in the first four weeks after delivery.

According to the company, Zulresso has reached the primary endpoint in all clinical trials at all doses, which corresponds to a significant average reduction in the total score of the badessment scale of depression from Hamilton (HAM-D).

Dr. Tiffany Farchione, Director of the FDA's Psychiatric Products and Research Division, said: "Postpartum depression can also interfere with the mother-child relationship. This approval marks the first time that a drug is specifically approved to treat postpartum depression, thus offering a new important treatment option.