Acadia’s schizophrenia drug flops in Phase 3 trial
pharmafile | July 23, 2019 | News story | Manufacturing and Production | acadia, clinical trials, menatl health, neuroscience, pharma, phase 3, schizophrenia
Acadia Pharmaceuticals has said its schizophrenia drug Nuplazid (primavanserin) has failed to beat placebo in a Phase 3 trial.
Nuplazid did not improve symptoms as an adjunctive treatment in adult patients with schizophrenia who had shown persistent inadequate response to their current antipsychotic therapy.
In a trial of 396 patients with moderate-to-severe psychotic symptoms, the drug did not show statistically significant improvements when given on top of patients existing antipsychotic treatments, compared to placebo.
While Nuplazid did show a consistent trend in improving psychotic symptoms, these improvements were not statistically significant as measured on the Positive and Negative Syndrome Scale (PANNS), the ‘golden standard’ of assessment of psychotic behaviour.
The drug did however show some improvements in measures of ‘negative symptoms’ of schizophrenia, which include loss of motivation, lack of social interest and poverty of speech and thought/
“I want to thank all the patients, their families, and the investigators who participated in our ENHANCE study. Unfortunately, we did not achieve a statistically significant reduction in the PANSS total score in this study,” said Acadia’s President Dr Serge Stankovic.
“We are pleased with the improvement in negative symptoms observed in this study. We look forward to completing our ongoing ADVANCE trial evaluating pimavanserin in schizophrenia patients with predominant negative symptoms.”
Either way, the drug was well tolerated with similar rates of adverse events between adjunctive primvanserin (40.4%) and adjunctive placebo (36.9%). Nuplazid is currently approved as a treatment for Parkinson’s disease psychosis.
Louis Goss
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