Clinical trials of a new drug intended to control hallucinations associated with advanced Parkinson’s disease also have become a trial in perseverance for San Diego’s Acadia Pharmaceuticals (Nasdaq: ACAD).
Despite a big setback three years ago, the company is reporting some encouraging results today in a comeback study evaluating the efficacy, tolerability, and safety of its pimavanserin drug in treating Parkinson’s disease psychosis. The company says pimavanserin met the primary and key secondary endpoints in a pivotal late stage trial, which the company repeated—at a cost of roughly $15 million—after a similar trial failed in 2009.
The outcome means Acadia is now laying plans for what should be a final, confirmatory, pivotal trial of pimavanserin that would likely take two years to complete. Perhaps after that, Acadia says it would be in a position to submit a new drug application for pimavanserin with the FDA. (Acadia has scheduled a conference call and webcast with investors and financial analysts today, beginning at 8 a.m. ET.)
“We are very excited with the results of this study, which really shows the potential of pimavanserin,” Acadia CEO Uli Hacksell said in phone interview late yesterday. The drug represents “a really major unmet medical need,” he said, because pimavanserin—unlike other antipsychotics—can be combined with the drugs used in patients with Parkinson’s to control tremors and other motor control symptoms.
Acadia’s drug reduced hallucinations in nearly all Parkinson’s patients in the study, without worsening their … Next Page »