A Phase 3 clinical trial, CLARITY, evaluating ACADIA Pharmaceuticals’ (NASDAQ:ACAD) Nuplazid (pimavanserin) for the adjunctive treatment of major depressive disorder (MDD) failed to achieve the primary endpoint of a statistically significant change from baseline to week 5 in a scale called HAMD-17 compared to placebo.
Specifically, the mean reduction in HAMD-17 total score in the pimavanserin arm was 9.0 versus 8.1 in the control arm (p=0.296).
A key secondary endpoint, the change from baseline in a scale called CGI-1, was met (p=0.042) as was the change in Karolinska Sleepiness Scale (KSS) score.
No new safety signals were observed.
The company plans to combine the CLARITY-2 and CLARITY-3 trials. Both concluded with slightly greater than 50% enrollment.
The FDA approved pimavanserin, a non-dopaminergic antipsychotic, in April 2016 for Parkinson’s disease psychosis.
Management hosts a conference call today at 4:30 pm ET to discuss the results.
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