ACADIA Pharmaceuticals Inc., a biopharmaceutical company specialized in the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, has just announced it has filed for a New Drug Application with the US Food and Drug Administration for NUPLAZID (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease.
NUPLAZID is classified as an SSIA (selective serotonin inverse agonist), specifically targeting 5-HT2A receptors. Through this novel mechanism, NUPLAZID has been able to demonstrate significant improvement in Parkinson’s disease-related psychosis (PDP) all while minimizing the many debilitating side effects traditional antipsychotics cause. In fact, none of today’s available antipsychotics have been approved for the psychosis observed in Parkinson’s disease. This follows NUPLAZID’s Breakthrough Therapy Designation for PDP, which was granted in 2014.
Parkinson’s disease (PD) is a progressive neurodegenerative disorder characterized by loss of dopamine neurons and accumulation of alpha-synuclein protein deposits, forming toxic protein aggregates called Lewy bodies. The symptoms associated with PD include uncontrolled shaking, an unstable gait and cognitive loss.
The NDA was filed with supporting evidence from an extensive development program evaluating NUPLAZID’s safety and efficacy profile for PDP. This includes findings from a pivotal Phase III -020 trial which achieved all primary and secondary endpoints significantly. This study was able to demonstrate NUPLAZID’s ability to significantly reduce symptoms of psychosis in patients suffering from PDP, including improvements in secondary and exploratory efficacy measures, such as in nighttime sleep, daytime wakefulness and caregiver burden. Concurrent with previously completed studies, NUPLAZID was demonstrated to be safe and well tolerated.
The company has also requested the FDA a priority review of the NDA, which, if granted, can expedite the review process from the standard 10 months to only 6 months.
“NUPLAZID holds promise for patients with Parkinson’s disease psychosis who currently have no FDA-approved treatment options,” said Steve Davis, ACADIA’s Chief Executive Officer. “Psychosis is the leading cause for Parkinson’s patients moving from their homes to nursing homes or other institutions and leads to an increased risk of mortality, a diminished quality of life and significant caregiver burden. If approved, NUPLAZID would represent a new and distinctly different pharmacological approach to treating psychosis and would be the first drug approved in the United States for psychosis associated with Parkinson’s disease.”