Acadia’s Persistence With Pimavanserin In Parkinson’s Psychosis Pays Off
This article was originally published in Pharmaceutical Approvals Monthly
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.
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FDA is concerned the change shown by Acadia's proposed Parkinson's psychosis product may not be clinically meaningful.
Acadia's pimavanserin would be first treatment for psychosis related to Parkinson's, but it only succeeded after endpoint was refined in second Phase III trial.
Company says delay is due to manufacturing scale-up work and does not reflect any change in Parkinson’s psychosis drug’s efficacy or safety profile. In tandem with the news, CEO Hacksell retired, replaced on interim basis by CFO Davis.