23 Apr

Sage Postpartum Depression Drug Heads to FDA Review

A new treatment for postpartum depression has inched closer to market.

Sage Therapeutics this morning filed for FDA approval of brexanolone, which could become the company’s first marketed product as well as the first-ever drug approved specifically for PPD, which affects some 10 to 20 percent of women giving birth every year in the U.S.

In November, Sage’s (NASDAQ: SAGE) brexanolone succeeded in two Phase 3 trials in PPD, beating a placebo at reducing a measure of patients’ depression symptoms. Still, whether the drug-which requires a 60-hour IV infusion-will succeed commercially is an open question. In a recent research note,… Read more »

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