FDA approves Acadia Pharmaceuticals' Nuplazid

The US Food and Drug Administration has approved biotech firm Acadia Pharmaceuticals’ (Nasdaq: ACAD) Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. In 2014, the FDA designated Nuplazid as a Breakthrough Therapy for this condition.

“Today’s approval of Nuplazid represents a major paradigm shift in the treatment of Parkinson’s disease psychosis,” said Michael Okun, medical director of The National Parkinson Foundation. “Through its novel and selective mechanism of action, Nuplazid is a breakthrough treatment that works in a whole new way - treating hallucinations and delusions without blocking dopamine receptors and, therefore, not impairing motor function in Parkinson’s psychosis patients,” Dr Okun added.

Nuplazid is the first and only medicine to be approved by the FDA for this indication. Nuplazid is also the only drug approved by the FDA that preferentially targets 5-HT2A receptors. These receptors are thought to play an important role in Parkinson’s disease psychosis.