Acadia Files NDA for Parkinson’s Psychosis Drug
Acadia Pharmaceuticals last week filed an NDA with the FDA for Nuplazid, a product that, if approved, would be a first-in-class drug and the first specific treatment for Parkinson’s disease psychosis.
Nuplazid (pimavanserin) has the potential to avoid many of the debilitating side effects of existing antipsychotics, none of which are approved for use in PDP patients, says Acadia.
The submission is based on data from a pivotal Phase 3 study that showed Nuplazid significantly reduced psychosis with no worsening of motor function compared with placebo.
Acadia has requested a priority review of the NDA. If granted, it would cut the standard 10-month review time to six months.
The FDA granted Nuplazid breakthrough therapy designation for PDP in September 2014. — Jonathon Shacat