The US commercial launch for the drug is planned for June 2016
ACADIA Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved 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.
"This approval of NUPLAZID represents a major paradigm shift in the treatment of Parkinson's disease psychosis," said Dr Michael S. 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."
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.
The unique pharmacology of NUPLAZID establishes a new class of drug - selective serotonin inverse agonists (SSIA) - by not only preferentially targeting 5-HT2A receptors but also avoiding activity at dopamine and other receptors commonly targeted by antipsychotics. Typical Parkinson's disease therapy consists of drugs that stimulate dopamine to treat patients' motor symptoms such as tremor, muscle rigidity and difficulty with walking. NUPLAZID does not interfere with patients' dopaminergic therapy and therefore does not impair their motor function.
"NUPLAZID represents a major medical advancement for patients with Parkinson's disease psychosis who suffer from hallucinations and delusions," said Mr Steve Davis, ACADIA's president and chief executive officer. "We are grateful to the many patients and investigators who participated in NUPLAZID's clinical studies. NUPLAZID represents the culmination of many years of work across our entire organization to bring this novel medicine, discovered by our scientists, to patients in need."