7 February 2018 - Designation offers potential for expedited development and review, and highlights the urgent need for additional treatment options for patients suffering from depression.

Sage Therapeutics today announced that the U.S. FDA granted breakthrough therapy designation to SAGE-217 for the treatment of major depressive disorder (MDD). This is the second breakthrough therapy designation granted to Sage since 2016.

The breakthrough therapy designation is intended to offer a potentially expedited development path and review for promising drug candidates, which includes increased interaction and guidance from the FDA. This regulatory decision was based primarily on the recent positive results from the Phase 2, placebo-controlled trial of SAGE-217 in 89 adult patients with moderate to severe MDD. In the trial, SAGE-217 met the primary endpoint with a statistically significant mean reduction in the Hamilton Rating Scale for Depression (HAM-D) 17-item total score from baseline at Day 15 in the SAGE-217 group, compared to placebo (p<0.0001). Statistically significant improvements were observed in the HAM-D score compared to placebo by the morning following the first dose through Week 4 and the effects of SAGE-217 remained numerically greater than placebo through the end of follow-up at Week 6. SAGE-217 was generally well-tolerated. The most common adverse events in the SAGE-217 group were headache, dizziness, nausea, and somnolence.

Read SAGE Therapeutics press release