The U.S. Food and Drug Administration accepted Acadia Pharmaceuticals Inc.'s application for expanded use of Nuplazid, while the drug failed to improve the condition of patients with depression in a phase 3 trial.
Nuplazid has been approved in the U.S. since 2016 for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
The San Diego-based company filed an application with the U.S. regulator in June seeking marketing authorization of Nuplazid, or pimavanserin, for the treatment of hallucinations and delusions in patients with dementia-related psychosis.
Psychosis is a condition in which it becomes difficult for a person to discern what is real. Trauma, extreme stress, and physical or mental conditions, including dementia, can cause psychosis.
Dementia is characterized by deterioration in memory, thinking, behavior and the ability to perform everyday activities. There are about 8 million patients with dementia in the U.S., according to Acadia's July 20 news release. Almost 30% experience psychosis, and only half of them, or 1.2 million, are diagnosed and treated.
The application is based on results from the phase 3 trial called Harmony, which showed that Nuplazid reduced the risk of psychosis relapse by almost three times compared to placebo.
The FDA expects to make a decision on the application by April 3, 2021, and has previously granted the drug a breakthrough-therapy status.
Phase 3 depression trial
Nuplazid, in combination with standard treatment, was unable to significantly improve symptoms of patients with major depressive disorder in a phase 3 trial dubbed Clarity.
A once-daily dose of Nuplazid was compared with placebo during the trial, which evaluated 298 patients. There was no significant difference in the change of depression symptoms in both treatment groups after five weeks.
The drug underwent a post-approval safety review in 2018 for a reported connection to hundreds of deaths. It was later cleared by the FDA in 2019 and carries a boxed warning for an increased risk of death in elderly patients with dementia-related psychosis.
Acadia has also evaluated the Nuplazid for the treatment of schizophrenia and Alzheimer's disease. Nuplazid in combination with antipsychotic treatment failed to improve the symptoms of patients with schizophrenia in the late-stage study.