Acadia's Pimavanserin Misses Primary Endpoint In Phase 3 Trial

(RTTNews) - Acadia Pharmaceuticals Inc. (ACAD) Monday said a late stage study evaluating treatment of depressive disorder didn't achieve primary endpoint.

The company announced top-line results from its 298 patient Phase 3 CLARITY study which combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of pimavanserin as an adjunctive treatment for major depressive disorder.

The study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale total score change from baseline to week 5.

Pimavanserin, given once-daily as an adjunctive treatment to standard antidepressant therapy was associated with a mean reduction of 9.0 in HAMD-17 total score compared to 8.1 for placebo as an adjunctive treatment.

"We observed a consistent improvement of depressive symptoms over time with pimavanserin but, unfortunately, the robust positive results from our CLARITY-1 study were not replicated," said Serge Stankovic, ACADIA's President.

Separately, Acadia announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application for Nuplazid for the treatment of hallucinations and delusions associated with dementia-related psychosis.

"We are pleased that the FDA has accepted our sNDA for filing and we will be working closely with the FDA to facilitate completion of the review in a timely manner," said Steve Davis, ACADIA's Chief Executive Officer.

If approved, Nuplazid would be the first therapy indicated for the treatment of hallucinations and delusions associated with dementia-related psychosis.