The FDA has issued a Complete Response Letter (CRL) for Acorda Therapeutics’ Plumiaz diazepam nasal spray for the treatment of cluster seizures in epilepsy patients, the company has announced. Acorda submitted a 505(b)(2) application for the product in November 2013. The company acquired the product along with its developer Neuronex in 2012.
The CRL means that the product is unlikely to receive FDA approval in 2014, Acorda said.
Acorda President and CEO Ron Cohen commented, “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.”
Read the Acorda press release.
