Sage Postpartum Depression Drug Heads to FDA Review

Xconomy Boston — 

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, for instance, RBC Capital Markets Brian Abrahams wrote that it “will be critical for the drug’s adoption” for home infusions to be available, rather than hospital IV infusions.

Sage is also testing a pill, SAGE-217, for PPD that has already shown promise in placebo controlled tests for major depressive disorder and is meant to work similarly to brexanolone—both target a neurotransmitter called GABA, though SAGE-217 has yet to prove it’s as effective as brexanolone in women with PPD. A Phase 2 study is currently underway, with results expected later this year.

Here’s more on Sage, brexanolone, and SAGE-217.