US biotech firm ACADIA Pharmaceuticals (Nasdaq: ACAD) says that new date published in the on-line edition of The Lancet today (November 1) from its pivotal Phase III -020 Study with pimavanserin in patients with Parkinson’s disease psychosis (PDP) demonstrated significant and clinically meaningful benefits and showed the drug was safe and well tolerated in patients with PDP.
Pimavanserin significantly reduced psychosis and maintained motor control in patients with PDP. Significant benefits were also observed in exploratory measures of night-time sleep, daytime wakefulness and caregiver burden.
Earlier this year, the Food and Drug Administration agreed that the data from the pivotal Phase III -020 study, together with supportive data from other studies with pimavanserin, are sufficient to support the filing of a New Drug Application for the treatment of Parkinson’s disease psychosis (PDP; The Pharma Letter April 11). Pimavanserin is partnered with Canadian biotechnology firm Biovail (TSE: BVF) under a deal which could earn the US group as much as $395.0 million.
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