The US Food and Drug Administration (FDA) has approved United States-based Sage Therapeutics' Zulresso (brexanolone) injection intended for the treatment of postpartum depression (PPD) in adult women, it was reported yesterday.
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 product is claimed to be the first and only medicine to have secured approval to treat PPD, which is the most common medical complication of childbirth. It is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors.
The firm is planning to introduce the product in late June after scheduling by the US Drug Enforcement Administration, which is expected to take place within 90 days. It has also received PRIority Medicines (PRIME) designation for Zulresso from the European Medicines Agency (EMA).
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