The U.S. Food and Drug Administration (FDA) will review Acadia Pharmaceutical’s application asking that Nuplazid (pimavanserin) also be approved to treat hallucinations and delusions associated with various forms of dementia-related psychosis, the company announced.
The supplemental new drug application (sNDA) was granted standard review status, and the FDA’s decision is expected by April 3, 2021. The regulatory agency found no issues with the application, and is not planning to request an advisory committee‘s independent advice and recommendations.
Nuplazid targets a group of receptors, called serotonin 5-HT2A receptors, known to play an important role in psychosis, schizophrenia, depression, and other neuropsychiatric disorders. The therapy is a selective serotonin inverse agonist (SSIA), meaning it binds to these receptors. But instead of activating them, it blocks their activity.
Nuplazid was approved under FDA’s breakthrough therapy designation to treat hallucinations and delusions associated with psychosis in people with Parkinson’s disease. This July 2018 approval was based on evidence showing Nuplazid’s use lessened symptoms of Parkinson’s-related psychosis, while minimizing the debilitating side effects that many antipsychotics cause.
Results from three clinical trials support the sNDA, including the Phase 3 HARMONY study (NCT03325556) that randomized 351 people with dementia-related psychosis to one of two daily doses of Nuplazid — 34 mg or 20 mg capsules — or a placebo Patients were followed for up to 26 weeks or until a psychosis relapse.
The trial met its main goal, with Nuplazid-treated patients showing a significant 2.8-fold reduction in the risk of a psychosis relapse compared with placebo. Nuplazid was well-tolerated, and was not associated with cognitive decline over the nine-month testing period.
HARMONY was open to patients with Alzheimer’s- and Parkinson’s-related dementia, dementia with Lewy bodies, vascular dementia, and frontotemporal dementia.
Data from two other trials, a Phase 2 trial in patients with Alzheimer’s-related psychosis (NCT02035553) and a Phase 3 trial investigating Nuplazid’s use in Parkinson’s psychosis (NCT01174004), further confirmed the positive antipsychotic effectiveness of this oral treatment.
Safety data from over 1,500 people with a neurodegenerative disease who enrolled in completed and ongoing clinical studies were also included in the sNDA, Acadia announced.
“We are pleased that the FDA has accepted our sNDA for filing and we will be working closely with the FDA to facilitate completion of the review in a timely manner,” Steve Davis, the company’s CEO, said in a press release.
“If approved, NUPLAZID would be the first therapy indicated for the treatment of hallucinations and delusions associated with dementia-related psychosis. We look forward to potentially bringing this important treatment advancement to patients, caregivers and physicians,” Davis added.
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