Pimavanserin Misses Primary End Point in Schizophrenia Study

Adjunctive treatment with pimavanserin did not result in a statistically significant change from baseline in Positive and Negative Syndrome Scale (PANSS) total score in patients with schizophrenia, according to results from the ENHANCE study.

The phase 3 trial was a 6-week, double blind, placebo controlled, outpatient study that evaluated the efficacy and safety of adjunctive pimavanserin in patients with schizophrenia who had not achieved an adequate response on their current antipsychotic treatment. Patients (N=396) were randomized to receive either pimavanserin or placebo once daily, in addition to a background antipsychotic. 

Results showed that while the addition of pimavanserin to antipsychotic treatment showed a consistent trend in improvement of psychotic symptoms (significant improvements seen on secondary endpoints of PANSS negative symptoms scale sub-score [unadjusted P =.0474] and PANSS Marder negative factor score [unadjusted P =.0362]), the results did not achieve statistical significance on the primary end point (PANSS) total score (P =.0940). 

Commenting on the study results, Serge Stankovic, MD, MSPH, ACADIA’s President said, “Unfortunately, we did not achieve a statistically significant reduction in the PANSS total score in this study. We look forward to completing our ongoing ADVANCE trial evaluating pimavanserin in schizophrenia patients with predominant negative symptoms.”

Additional results from the ENHANCE study will be presented at a future medical meeting, according to the Company.

Pimavanserin (Nuplazid), an atypical antipsychotic, is currently approved for the treatment of hallucinations and delusions associated with Parkinson disease (PD) psychosis.

For more information visit acadia-pharm.com.

This article originally appeared on MPR