The FDA has granted priority review for Acadia Pharmaceutical Inc's new drug application (NDA) for pimavanserin (Nuplazid) to treat psychosis associated with Parkinson's disease.
The FDA has granted priority review for Acadia Pharmaceutical Inc’s new drug application (NDA) for pimavanserin (Nuplazid) to treat psychosis associated with Parkinson’s disease.
Nuplazid was given breakthrough therapy designation back in 2014.
The treatment is a new class of non-dopaminergic antipsychotic that acts as a selective serotonin inverse agonist (SSIA). It targets 5-HT2A receptors and has shown to be effective in treating Parkinson’s disease psychosis, according to Acadia.
The NDA submitted to the FDA included data from a phase 3 study demonstrating that Nuplazid met both primary and secondary efficacy endpoints with no worsening of motor function in patients.
“The FDA priority review designation underscores the potential for Nuplazid to provide an important treatment to patients with Parkinson’s disease psychosis, a condition for which there is no FDA-approved therapy,” said Steve Davis, president and CEO of Acadia, in a press release. “We look forward to working with the FDA during the review.”
Previous research has suggested that pimavanserin could be used to treat psychotic conditions associated with other neurodegenerative conditions, such as Alzheimer’s disease.