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news.Acorda Therapeutics has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for Plumiaz (diazepam) nasal spray for the treatment of people with epilepsy who experience cluster seizures.
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The company is currently developing a response to address the items outlined in the letter.
Acorda president and CEO Dr Ron Cohen noted that there is an urgent need for new treatments for people with epilepsy who experience cluster seizures.
"We are committed to the development and commercialization of PLUMIAZ, a potential therapeutic option for these individuals.
"We are evaluating the Complete Response Letter and expect to work closely with the FDA to address the items outlined in the letter and refile the NDA for PLUMIAZ. We expect to provide further detail as our discussions with the FDA progress," Dr Cohen added.
Based on the requirements for approval outlined in the letter, the company does not expect Plumiaz to receive FDA approval in 2014.
Plumiaz has received orphan drug designation for the treatment of cluster seizures.