Zulresso is claimed to be the first and only medicine secured approval to treat PPD, which is the most common medical complication of childbirth.
The medicine is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity is said to result in varying degrees of desired activity rather than complete activation or inhibition of the receptor.
The company is planning to launch Zulresso in late June after scheduling by the US Drug Enforcement Administration, which is expected to take place within 90 days.
The FDA has assessed new PPD treatment under priority review. In 2016, the company secured breakthrough therapy designation for Zulresso.
The firm also secured PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) for Zulresso.
Sage Therapeutics CEO Dr Jeff Jonas said: “Zulresso will address an important need for women’s mental health, the impact of PPD is multi-generational, and we look forward to bringing ZULRESSO to patients in urgent need of a new treatment option.”
The approval was based on data from three multicenter, randomized, double-blind, parallel-group and placebo-controlled trials designed to assess the safety and effectiveness of Zulresso in women with moderate and severe PPD aged between 18 and 45 years.
The patients in the trial were ≤6 months postpartum at screening and who had onset of symptoms no earlier than the third trimester and no later than the first four weeks following delivery.
According to the company, Zulresso achieved the primary endpoint in all trials at all doses, which is a significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score.
The FDA’s Center for Drug Evaluation and Research psychiatry products division acting director Dr Tiffany Farchione said: “Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”