The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SAGE-217 (Sage), a potential treatment for major depressive disorder (MDD).
SAGE-217 is a next generation positive allosteric modulator that targets synaptic and extrasynaptic GABA receptors. The FDA based their Breakthrough therapy decision on recent results from a Phase 2, placebo-controlled trial involving 89 adult patients with moderate to severe MDD.
In the trial, patients administered SAGE-217 had a statistically significant mean reduction in the Hamilton Rating Scale for Depression (HAM-D) 17-Item total score from baseline to Day 15 of 17.6 points, compared to 10.7 for placebo (P<0.0001). The effects of SAGE-217 remained numerically greater than placebo through the end of follow-up at Week 6. Treatment was generally well-tolerated; the most common adverse events included headache, dizziness, nausea, and somnolence.
Breakthrough Therapy designation is intended to offer a potentially expedited development path and review.
For more information visit Sagerx.com.