Acadia’s Persistence With Pimavanserin In Parkinson’s Psychosis Pays Off
This article was originally published in The Pink Sheet Daily
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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Acadia’s serotonin 5-HT2A receptor blocker demonstrated efficacy in a Phase III trial in patients with Parkinson’s disease psychosis, giving the drug a second chance to reach the market. Pimavanserin previously failed to demonstrate efficacy in an original Phase III trial.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.
Part 1: Execs from rare disease-focused companies weighed in on investor sentiment during a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference.