Acorda to Discontinue Epilepsy Drug Development
May 20 2016 - 7:50AM
Dow Jones News
Acorda Therapeutics Inc. on Friday said it would discontinue
development of its Plumiaz epilepsy drug as continuing trials
didn't produce the data necessary to refile the new drug
application with federal regulators.
Acorda said clinical trial data didn't demonstrate the nasal
therapy's bioequivalence to Diastat—a rectal gel form of
diazepam—required for resubmission to the U.S. Food and Drug
Administration. The therapy was being studied for the treatment of
seizure clusters in people with epilepsy.
Acorda said the data demonstrated "unexpectedly lower nasal
mucosa absorption of diazepam" in patients with epilepsy compared
to studies in healthy volunteers.
"We are very disappointed by this outcome, and for those in the
epilepsy community who experience seizure clusters," Chief
Executive Ron Cohen said.
He said the company will continue to focus on development of its
other high potential pipeline programs, including treatments for
Parkinson's disease and post-stroke walking difficulty.
In 2012 was given orphan drug status by the FDA, meaning it was
developed to treat a rare condition or disease. Acorda submitted a
new drug application in 2013, but the FDA didn't grant approval.
The drug company planned three clinical trials for Plumiaz and had
planned to resubmit the application in 2017.
On Friday, Acorda said it would discontinue all continuing
clinical trials and present the data at a future medical
meeting.
Shares, inactive premarket, have lost a quarter of their value
over the past three months.
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
May 20, 2016 07:35 ET (11:35 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
Acorda Therapeutics (NASDAQ:ACOR)
Historical Stock Chart
From Aug 2024 to Sep 2024
Acorda Therapeutics (NASDAQ:ACOR)
Historical Stock Chart
From Sep 2023 to Sep 2024