May 2 Acorda Therapeutics Inc said the
U.S. Food and Drug Administration rejected its nasal spray to
treat epilepsy patients who experience repetitive seizures.
The drugmaker did not disclose the reason for the rejection,
but said it planned to resubmit the application for the
Acorda said on Friday that it does not expect the treatment,
Plumiaz, to receive regulatory approval this year based on the
requirements outlined in the complete response letter.
A complete response letter lists regulatory concerns that
need to be addressed before a medicine is approved.
About 175,000 of the 2.8 million people in the United States
with epilepsy experience so-called cluster seizures, Acorda
(Reporting by Natalie Grover in Bangalore; Editing by Sriraj