Acadia Pharmaceuticals can apply for approval of Parkinson's disease psychosis drug early

Company will not perform additional phase-3 trial of pimavanserin

SAN DIEGO — The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

Acadia Pharmaceuticals announced that the FDA had allowed it to move forward in applying for approval of the drug pimavanserin for the treatment of Parkinson's disease psychosis, or PDP, based on data from an already complete phase-3 trial and other data. The decision by the FDA means the company no longer perform another phase-3 trial that it had planned.

"We are very pleased with the outcome of our meeting with the FDA, which we expect will reduce substantially both the time and cost of our PDP development program," Acadia CEO Uli Hacksell said. "This represents another important step toward our goal of bringing pimavanserin to the market as an innovative therapy for Parkinson's patients who suffer from the psychosis frequently associated with this disease."

Of the 1 million people in the United States with Parkinson's disease, about 60% develop PDP, a condition that causes visual hallucinations and delusions, according to the National Parkinson's Foundation. There is currently no FDA-approved treatment for PDP, Acadia said.


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