Sage Bounces Back, Eyes FDA Filing for Postpartum Drug
Summary
Sage Therapeutics reported this morning that an experimental neurological drug known as brexanolone succeeded in two Phase 3 trials, setting the stage for an FDA approval filing next year.The drug led to a statistically significant reduction, compared to a placebo, in a measure of patients’ depression symptoms known as the HAM-D scale 60 hours after they were treated.In a note to investors, Leerink Partners analyst Paul Matteis said the results don’t quite match the “too good to be true” results the drug posted in earlier studies—in a Phase 2 trial published in the peer reviewed journal the Lancet, the drug’s HAM-D scores were close to 12 points better than a placebo.On a conference call in September, CEO Jeff Jonas cited differences in the diseases themselves, the variability in the underlying cause that led to patients’ SRSE, and the “consistency of data” the drug had generated to that point in PPD.And depression studies are notoriously troublesome due to high placebo responses that can doom trials and make results difficult to interpret.