Esketamine: Phase II data

The double-blind, U.S. Phase II PeRSEVERe trial in 68 MDD patients ages 18-64 assessed to be at imminent risk for suicide showed that twice-weekly 84 mg intranasal esketamine plus standard of care (SOC) for 4 weeks met the primary endpoint of improving MADRS total score from baseline to 4 hours post-dose on day 1 vs. placebo plus SOC (mean difference of 5.3 points, p=0.015). Esketamine plus SOC also met the secondary endpoints of improving MADRS total score from baseline to day 2 (mean difference of 7.2 points, p=0.015) and of improving MADRS suicide item score from baseline to 4 hours post-dose on day 1 (p=0.002) vs. placebo plus SOC. Esketamine non-significantly improved MADRS total score from baseline to day 25 (mean difference of 4.5 points, p=0.159) and MADRS suicide item score from baseline to day 2 (p=0.129) and day 25 (p=0.143) vs. placebo plus SOC. Esketamine was generally well tolerated with nausea, dizziness, dysgeusia, headache, dissociation and vomiting reported as the most common treatment-emergent adverse events. There were 4 treatment-emergent serious adverse events reported in the esketamine arm, including suicide ideation, agitation and depressive symptoms. SOC included hospitalization and treatment with oral antidepressant medication. Data were presented at the Society of Biological Psychiatry meeting in Atlanta last May. ...