FDA issues CRL over Acorda's Plumiaz marketing application

There was disappointment for US biotech firm Acorda Therapeutics (Nasdaq: ACOR), which says it has received a complete response letter from the US Food and Drug Administration related to its New Drug Application for Plumiaz (diazepam) Nasal Spray for the treatment of people with epilepsy who experience cluster seizures.

Based on the requirements for approval outlined in the letter, Acorda says it does not expect Plumiaz to receive FDA approval in 2014. The company is currently developing a response to address the items outlined in the CRL.

“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,” said Ron Cohen, Acorda’s president and chief executive. “We are evaluating the Complete Response Letter and expect to work closely with the FDA to address the items outlined in the letter and re-file the NDA for Plumiaz. We expect to provide further detail as our discussions with the FDA progress.”