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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Acorda Therapeutics Inc | NASDAQ:ACOR | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.661 | 0.565 | 0.5878 | 0 | 01:00:00 |
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.
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