NEW YORK (AP) — Acadia Pharmaceuticals Inc. said Thursday that it won’t have to run a second late-stage trial of its drug pimavanserin, a treatment for psychosis associated with Parkinson’s disease. Its shares surged in premarket trading.
The San Diego company said the Food and Drug Administration agreed that results from Acadia’s previous clinical trials and other clinical data are enough to support a filing for marketing approval. As a result the company said it is canceling a second late-stage study of the drug.
Acadia said it expects to file for marketing approval of pimavanserin in late 2014, after it completes other forms of testing.
The FDA’s decision means pimavanserin could be approved sooner and saves Acadia the cost of running another trial.
Acadia stock surged $3.30, or 41.4 percent, to $11.27 in premarket trading. The shares are already trading around five-year highs and were on pace to open at their highest price since January 2008.
Acadia says up to 60 percent of Americans with Parkinson’s disease develop psychosis and there is no approved therapy to treat the condition. The company said anti-psychotic drugs are sometimes used, but those drugs can increase the risk of death and cause side effects like further loss of motor control. Acadia does not have any approved products and pimavanserin is its most advanced experimental drug.
Acadia shares rose as high as $8.81 on March 21 after the company said pimavanserin met a series of secondary goals in a late-stage trial. Acadia had said in November that the drug reached its main goals in the study.