ACADIA Pharma files for US approval of Nuplazid for Parkinson's disease

3 September 2015

Shares of US biotech firm ACADIA Pharmaceuticals (Nasdaq: ACAD) leapt 10.7% to $42.13, on the news it has submitted a New Drug Application to the US Food and Drug Administration seeking approval for Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease.

Nuplazid is a (selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors. Through this novel mechanism, the drug 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.

Follows delay earlier this year

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