FDA sets a decision date for Sage’s postpartum depression pill

The Cambridge company’s promising treatment could get a green light by Aug. 6, and on the market before year’s end.

The Food and Drug Administration has accepted Cambridge biotech Sage Therapeutics' application for a pill to treat postpartum depression.Manuel Balce Ceneta/Associated Press

An experimental drug that in a clinical trial helped some women quickly recover from postpartum depression could be approved by federal regulators by Aug. 6. The medicine, developed by Sage Therapeutics, is poised to become the first pill for the condition, which afflicts as many as 1 in 8 new mothers.

The Cambridge company on Monday announced the Food and Drug Administration’s decision date for the drug. Sage is still waiting to hear if the agency will convene an advisory committee of independent scientists to review the medicine’s safety and effectiveness before August.

The news comes amidst a spotlight on postpartum mental illness in New England following the case of Lindsay Clancy, the Duxbury mother charged with killing two of her children and strangling a third, who later died. Clancy had earlier said on social media that she was struggling with postpartum depression.

Sage already markets the only drug specifically approved for postpartum depression. Zulresso, which is administered as an infusion over 60 hours in a hospital. But few hospitals offer the drug, and Sage has said that only hundreds of women have gotten the $34,000 one-time treatment.

The new drug, called zuranolone, could reach far more people because it is taken as a once-a-day pill for two weeks. In a recent clinical study, 57 percent of people who received for two weeks saw their postpartum depression decrease, compared to 38.9 percent of those who got placebo pills, an effect that psychiatrists said was significant.

Moved by earlier promising data on the drug, Cambridge-based Biogen paid Sage $1.5 billion in 2020 to jointly develop zuranolone and another experimental drug made by Sage. The companies hope zuranolone will reach many of the estimated 500,000 cases of postpartum depression in the United States each year, but they are also aiming to capture a chunk of the much broader market for antidepressants.

While the most commonly prescribed antidepressants boost concentrations of a neurochemical called serotonin, zuranolone acts on a different neurochemical called GABA. Sage believes the drug’s faster-acting and potentially longer-lived effects are due to its ability to rewire communications between brain regions that rely on GABA, which become disrupted during depression.

Sage has tested its two-week course of zuranolone in several clinical studies of people with major depressive disorder, with mostly positive results. About 21 million adults experience a major depressive episode each year, but Sage is focusing its launch on the 6 to 7 million people who have already tried at least one antidepressant and are looking to try a different drug.

Sage submitted zuranolone to the FDA in December, and has been waiting to hear back about whether it would get a speedier priority review of six months rather than the standard review, which can take 10 months. If the drug is approved, it will then undergo a three-month review by the Drug Enforcement Agency. After that, it could be on the market by the end of the year.