Acorda Therapeutics announced that it will discontinue development of Plumiaz (diazepam) Nasal Spray, a therapy under investigation for the treatment of seizure clusters in patients with epilepsy.
Findings from ongoing clinical trials failed to demonstrate its bioequivalence to Diastat rectal gel, a requirement needed to re-file the New Drug Application (NDA). Study data showed that Plumiaz had lower nasal mucosa absorption in patients with epilepsy compared to studies in healthy volunteers.
The company is working with study investigators to facilitate the discontinuation of all ongoing clinical trials and to assist in the transition of study participants. Acorda plans to present study data at a future medical meeting.
Acorda submitted the NDA for Plumiaz for the treatment of patients with epilepsy who experience cluster seizures in 2014. In response, the FDA issued a Complete Response Letter (CRL) for the NDA in May 2014.
For more information visit Acorda.com.