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Acadia’s Persistence With Pimavanserin In Parkinson’s Psychosis Pays Off

 
• By Emily Hayes

After meeting with FDA, Acadia announces it needs only one pivotal study for pimavanserin. The company has canceled a second study and expects to file at the end of 2014. Faster NDA pathway could mean launch a year earlier than expected.

Acadia Pharmaceuticals Inc.’s persistence in adapting the clinical trial design for pimavanserin after an early failure in Parkinson’s disease psychosis has paid off, with assurance from FDA that the single positive Phase III trial the firm has already conducted will be sufficient for filing.

Pimavanserin (ACP-103) is a first-in-class, oral antagonist/inverse agonist of serotonin 5-HT2A receptors wholly owned by Acadia. The firm lost its development partner after a Phase III failure in 2009, but...

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