The FDA announced Tuesday that it has cleared Sage Therapeutics' Zulresso (brexanolone) to treat postpartum depression (PPD) in adult women, making it the first drug approved in the US specifically for this indication. Zulresso, which is delivered as a continuous intravenous infusion over 60 hours, comes with a boxed warning about certain risks, including excessive sedation or sudden loss of consciousness during administration. 

Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, noted that the drug was approved with a Risk Evaluation and Mitigation Strategy and is only available to patients through a restricted distribution programme at certified healthcare facilities. Sage said Zulresso is expected to be available in late June following scheduling by the US Drug Enforcement Administration. 

According to the FDA, Sage's filing for Zulresso, formerly known as SAGE-547, was approved based on data from two Phase III trials, showing that the drug helped to significantly reduce symptoms of depression compared with placebo in patients with moderate or severe PPD. The agency noted that superiority over placebo was seen at the end of the first Zulresso infusion, and that the effect was maintained through the 30-day follow-up. Last November, an FDA advisory committee voted 17 to 1 recommending approval of the drug, an allosteric modulator of synaptic and extra-synaptic GABA-A receptors. 

The company said the list price for the drug would be $7450 per vial, resulting in a projected average cost of $34 000 per patient before discounts, not counting the costs of staying in a medical centre for treatment. Guggenheim analyst Yatin Suneja expects Zulresso to generate peak sales of approximately $300 million to $400 million, although Sanjay Mathew of the Anxiety and Depression Association of America suggested the drug was not likely to have "significant uptake given the requirements for [intravenous] infusion and duration of the infusion." Company officials indicated that they expect insurers will cover the treatment, while insurers said this week that they are evaluating the drug. 

The FDA's approval comes after the agency extended its review of the drug late last year by three months. Zulresso has been granted breakthrough therapy status by the FDA for the treatment of PPD, and has also received PRIME designation by the European Medicines Agency for the same indication. 

Meanwhile, Sage is also working on SAGE-217, a more convenient oral drug formulation for PPD. Earlier this year, the company reported top-line results from the Phase III ROBIN trial showing that SAGE-217 had significantly improved depressive symptoms versus placebo after two weeks of treatment in women suffering from PPD, with adverse events similar to those seen with placebo and no reports of loss of consciousness. 

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