Sage Therapeutics Inc. said a phase 2 study of SAGE-217 in patients with moderate to severe major depressive disorder met its main goal.
In the trial conducted among 89 adult patients, the drug showed a statistically significant mean reduction from baseline in the Hamilton Rating Scale for Depression, or HAM-D, of 17.6 points, compared to 10.7 points for placebo.
The Hamilton Rating Scale for Depression is a multiple-item questionnaire used to provide an indication of depression.
At 15 days, 64% of the patients treated with SAGE-217 achieved remission, as measured by a score of 7 or less on the scale, versus 23% for placebo-treated patients.
The medicine was generally well-tolerated in the trial. The most common side effects recorded were headache, dizziness, nausea and somnolence.
The U.S. Food and Drug Administration had granted the treatment a fast-track designation in May.
Sage Therapeutics' stock was up 72.83% after the news to $158.83 as of 3:04 p.m. ET on Dec. 7.