Pimavanserin appears to benefit patients with predominantly negative symptoms of schizophrenia, according to top-line results from a phase 2 trial.
The ADVANCE study was a double-blind, placebo-controlled trial that evaluated the safety and efficacy of adjunctive pimavanserin in patients with schizophrenia who have predominant negative symptoms while on a stable background antipsychotic therapy (N=403). The primary end point of the study was change from baseline to Week 26 in the Negative Symptom Assessment-16 (NSA-16) total score.
Results showed that treatment with pimavanserin led to a greater improvement in the NSA-16 total score compared with placebo (-10.4 vs. -8.5; P =.043; effect size = 0.21). Moreover, a greater improvement in NSA-16 total score vs placebo was observed in the 107 patients who received pimavanserin 34mg (-11.6 vs. -8.5; unadjusted P =.0065, effect size = 0.34). An additional trial evaluating the 34mg dose is expected to begin in the first half of 2020.
In July 2019, Acadia announced that the ENHANCE trial, which evaluated adjunctive pimavanserin in patients with schizophrenia who had not achieved an adequate response on their current antipsychotic treatment, did not meet its primary end point (change from baseline in Positive and Negative Syndrome Scale [PANSS] total score), however significant improvements were observed in PANSS negative symptoms scale sub-score (P=.0474; secondary end point).
“The negative symptoms of schizophrenia such as social withdrawal, apathy, anhedonia, loss of motivation, blunted affect, and restricted speech contribute significantly to low function levels, long-term disability, and increased caregiver burden,” said Dr Henry A. Nasrallah, MD, Professor of Psychiatry, Neurology, & Neuroscience, Director, Neuropsychiatry and Schizophrenia Programs, at the University of Cincinnati College of Medicine. “There are no FDA-approved treatments indicated for the treatment of the negative symptoms of schizophrenia and there remains a serious and significant unmet need.”
Pimavanserin (Nuplazid), an atypical antipsychotic, is currently approved for the treatment of hallucinations and delusions associated with Parkinson disease (PD) psychosis.
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