Rare FDA Ruling Triggers Stampede for Acadia Pharmaceuticals

stock biotech

How often does the FDA tell a drug developer to dispense with a requisite, second late-stage trial—and to proceed with filing a new drug application?

Shares of San Diego’s Acadia Pharmaceuticals (NASDAQ: [[ticker:ACAD]]) appreciated by two-thirds today, leaping from yesterday’s close of $7.97 a share to more than $13.30 in late mid-day trading on the Nasdaq market—after Acadia said the FDA agreed the company had enough compelling data for pimavanserin, its lead drug candidate proposed for treating for Parkinson’s disease psychosis.

The FDA usually requires at least two successful late-stage trials, but will accept a single trial under certain circumstances, such as a drug that satisfies an unmet medical need.

In today’s statement, Acadia says that after meeting recently with FDA regulators, the company no longer plans to conduct the second Phase 3 study that was planned as a confirmatory trial. That trial had been scheduled to begin this month.

In a conference call this morning with analysts and shareholders, Acadia Chief Medical Officer Roger G.M. Mills, said the company plans to conduct standard development studies and collect related data needed to submit an NDA, now targeted for the end of next year.

Mills said a meeting the company held with FDA regulators earlier this week was intended to show how the company’s pivotal study met the agency’s criteria for using a single study. According to a transcript prepared by Seeking Alpha, Mills said, “The pivotal -020 Study was a large, multicenter study with statistically very persuasive results that were consistent across study subsets. The -020 Study also assessed multiple endpoints involving different events including not only antipsychotic efficacy, but also positive effects on nighttime sleep, daytime wakefulness and on caregiver burden.”

In addition to the strength of results in the study, Mills said Parkinson’s psychosis is a serious unmet medical need without any approved treatment option. About 40 percent of patients with advanced Parkinson’s suffer from hallucinations and manifestations of psychosis, according to the National Institutes of Health. Parkinsons occurs in about 0.3 percent of the population of industrialized countries, affecting between eight and 18 people out of every 100,000.

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.