Biovail Corporation (BVF) recently provided an update on its development plans for pimavanserin for Parkinson’s disease psychosis (PDP). The company is developing the candidate in collaboration with Acadia Pharmaceuticals, Inc. (ACAD) and stated that the partners remain committed towards the successful development of the candidate.
In early Sept. 2009, the companies had reported results from a pivotal phase III study (-012 study) in which pimavanserin failed to meet its primary endpoint of antipsychotic efficacy due to an unexpectedly high placebo response rate. Based on an analysis of the data from this study, the partners have decided to continue with the development of the candidate.
The companies intend to use findings from the -012 study and an ongoing phase III study (-014 study) for a new phase III trial. The new study will be conducted using a 40 mg dose of pimavanserin and Biovail will be responsible for the cost of this trial. The companies expect to commence this study in the first half of 2010.
Meanwhile, Acadia will continue with its ongoing open-label safety extension studies in patients with PDP. In addition to the PDP indication, Biovail has plans to study the efficacy of pimavanserin as an adjunctive therapy for schizophrenia. Biovail and Acadia also intend to study develop pimavanserin for Alzheimer’s disease psychosis (ADP).
According to the National Parkinson Foundation, more than 1.5 million people in the US suffer from Parkinson’s disease and about 40% of patients with Parkinson’s may develop psychotic symptoms, commonly consisting of visual hallucinations and delusions.
Currently there is no approved treatment available in the US for PDP. Therefore, if Biovail and Acadia are successful in developing pimavanserin for PDP, the companies would be able to carve a nice niche for themselves in this market.
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