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 treatment.
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 said. (Reporting by Natalie Grover in Bangalore; Editing by Sriraj Kalluvila)