Acadia Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialisation of innovative medicines to address unmet medical needs in CNS disorders, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease.

Nuplazid, administered orally once-a-day, is an SSIA (selective serotonin inverse agonist) preferentially targeting 5-HT2A receptors that play an important role in psychosis. Through this novel mechanism, Nuplazid has demonstrated significant efficacy in Parkinson’s disease psychosis (PDP) and has the potential to avoid many of the debilitating side effects of existing antipsychotics, none of which are approved for use in PDP patients. The FDA granted Nuplazid Breakthrough Therapy designation for PDP in 2014.

“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.”

According to the National Parkinson Foundation, about one million people in the United States and from four to six million people worldwide suffer from Parkinson’s disease. An estimated 40 per cent of these patients have Parkinson’s disease psychosis, which is characterized by hallucinations and delusions. Currently, there is no FDA-approved therapy to treat Parkinson’s disease psychosis.

Acadia’s NDA submission is based on data from a comprehensive development programme assessing the safety and efficacy of  Nuplazid for Parkinson’s disease psychosis. The NDA includes data from the pivotal phase III -020 Study, in which Nuplazid met all primary and secondary endpoints with statistical significance, along with supportive data from other studies with Nuplazid. The -020 Study demonstrated that Nuplazid significantly reduced psychosis compared to placebo in patients with Parkinson’s disease psychosis with no worsening of motor function. These results were further supported by significant improvements in all secondary efficacy measures and by significant benefits in exploratory efficacy measures of nighttime sleep, daytime wakefulness and caregiver burden. Consistent with previous studies, Nuplazid was safe and well tolerated in the -020 Study. Detailed results of the -020 Study have been published in The Lancet.

Acadia has requested a Priority Review of its NDA. If granted, Priority Review status would accelerate the review timeline from ten months to six months following the conclusion of the 60 calendar day filing review period that begins on the FDA’s receipt of the NDA. The FDA informs the applicant of a Standard or Priority Review designation following the conclusion of this 60 calendar day period.

Separately, Acadia announced that its Board of Directors has appointed Steve Davis as chief executive officer.