In Comeback Study, Acadia Says Drug Controls Parkinson’s Psychosis

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: [[ticker: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

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Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.