SAN DIEGO - Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) disclosed that its Phase 3 ADVANCE-2 trial, which tested the efficacy of pimavanserin in treating negative symptoms of schizophrenia, did not meet its primary endpoint. The results, announced Monday, revealed that pimavanserin did not show a statistically significant difference from placebo on the Negative Symptom Assessment-16 (NSA-16) scale after 26 weeks of treatment.
The study involved 454 adult patients who, while having their positive symptoms of schizophrenia under control with ongoing antipsychotic treatment, exhibited predominant negative symptoms. These symptoms include social withdrawal, lack of motivation, and reduced emotional expression, which can severely impact a patient's quality of life.
Despite the setback, the safety profile of pimavanserin was consistent with that observed in previous clinical trials, with a lower rate of adverse events compared to placebo (30.4% vs. 40.3%). Acadia's CEO, Steve Davis, expressed disappointment in the trial's outcome, acknowledging the significant unmet need for effective treatments for the negative symptoms of schizophrenia. He confirmed that the company does not plan to pursue further clinical trials for pimavanserin in this indication.
Pimavanserin is already approved by the FDA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Acadia Pharmaceuticals has been a pioneer in neuroscience for three decades, also developing the first and only FDA-approved drug for the treatment of Rett syndrome.
The company's ongoing clinical-stage development efforts include potential treatments for Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms associated with central nervous system disorders.
The information for this report is based on a press release statement from Acadia Pharmaceuticals.
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