Top-Line Data Expected in the Third Quarter of 2009
ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD) and Biovail Corporation
(NYSE:BVF) (TSX:BVF), today 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-HT2A 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.
