ACADIA And Biovail Announce Completion Of Enrollment In First Pivotal Phase III Trial With Pimavanserin In Patients With Parkinson's Disease Psychosis

Main Category: Parkinson's Disease
Also Included In: Clinical Trials / Drug Trials
Article Date: 07 May 2009 - 7:00 PDT

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ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD) and Biovail Corporation (NYSE:BVF) (TSX:BVF), announced the completion of enrollment in the first pivotal Phase III clinical trial of pimavanserin in patients with Parkinson's disease psychosis (PDP). Top-line results from this trial are expected to be announced by the end of the third quarter of 2009.

The Phase III trial is a multi-center, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of pimavanserin in patients with PDP. A total of 298 patients were enrolled in the trial and randomized to one of three study arms, including two different doses of pimavanserin (10 mg or 40 mg daily) and one placebo arm. Patients receive oral doses of either pimavanserin or placebo once daily for six weeks in addition to stable doses of their existing dopamine replacement therapy.

Patient enrollment in the second pivotal Phase III clinical trial of pimavanserin in PDP is ongoing. The primary endpoint of each of the Phase III trials is antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Motoric tolerability is an important secondary endpoint in the Phase III trials and is measured using the Unified Parkinson's Disease Rating Scale, or UPDRS (Parts II and III).

About Pimavanserin

Pimavanserin is a 5-HT_2A receptor inverse agonist in Phase III development as a treatment for Parkinson's disease psychosis. This new chemical entity, which was discovered by ACADIA, is a small molecule that can be taken orally as a tablet once-a-day. ACADIA and Biovail Laboratories International SRL, a subsidiary of Biovail, have formed a collaboration to co-develop and commercialize pimavanserin for neurological and psychiatric indications in the United States and Canada. ACADIA retains rights to pimavanserin in the rest of the world.

About Parkinson's Disease Psychosis (PDP)

According to the National Parkinson Foundation, over 1.5 million people in the United States suffer from Parkinson's disease. Up to 40 percent of patients with Parkinson's disease may develop psychotic symptoms, commonly consisting of visual hallucinations and delusions. Currently there is no therapy in the United States approved to treat PDP. The development of psychosis in patients with Parkinson's disease is associated with increased caregiver burden, nursing home placement, and increased mortality.

Source
Biovail Corporation

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