Sage-Biogen depression drug shines in late-stage postpartum trial

June 1, 2022

An experimental drug from Sage Therapeutics and Biogen improved symptoms of postpartum depression after 15 days in a late-stage study, according to the partners.

If approved, the two-week, once-daily drug — zuranolone — would be the first oral medication specifically indicated to treat postpartum depression (PPD), one of the most common medical complications during and after pregnancy, affecting approximately one in eight women who have given birth in the U.S.

According to the companies, the 200-person phase 3 SKYLARK study of zuranolone met its primary and all key secondary endpoints. Women treated with zuranolone 50 mg demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, compared to placebo, as measured by a change from baseline in the 17-item Hamilton Rating Scale for Depression.

The study also met all key secondary endpoints with rapid and statistically significant improvement in depressive symptoms as early as day 3 for participants treated with zuranolone  compared to placebo.

Sage signed a deal worth up to $1.5 billion with Biogen in Nov. 2020 to develop both zuranolone and SAGE-324 (for essential tremor and other neurological disorders). 

Zuranolone is being developed for the treatment of major depressive disorder (MDD) as well. It improved depression symptoms in two late-stage studies, but there have been concerns about its effectiveness and durability. Critics were skeptical of study results released in June 2021 from a phase 3 WATERFALL study in major depressive disorder showed only a small-to-moderate efficacy benefit over the placebo, and a waning benefit over time.

Sage and Biogen have initiated a rolling submission of a New Drug Application (NDA) to the U.S. FDA for zuranolone in the treatment of MDD and plan to complete the MDD NDA filing in the second half of 2022. An associated NDA filing for PPD is anticipated in early 2023.