Acorda Therapeutics has announced that it will discontinue the development of Plumiaz (diazepam) nasal spray, an investigational therapy being studied for the treatment of seizure clusters in patients with epilepsy. Data from the ongoing clinical trials failed to demonstrate the product’s bioequivalence to Diastat AcuDial (diazepam) rectal gel (Valeant), which was needed to refile a new drug application (NDA) for Plumiaz.
Specifically, the data demonstrated unexpectedly lower nasal mucosa absorption of diazepam in patients with epilepsy compared with studies in healthy volunteers.
Plumiaz was granted orphan drug status from the FDA in July 2012, and Acorda submitted an NDA in 2013. In May 2014, the FDA issued a complete response letter, which informed Acorda that the application could not be approved in its present form.
In May 2015, the company announced that it would conduct three new clinical trials in participants ranging in age from 12 to 65 years. Pending the successful completion of these studies, the company planned to resubmit its NDA for Plumiaz in the first quarter of 2017.
Epilepsy is a neurological condition that produces seizures affecting a variety of mental and physical functions. Seizures occur when a brief, strong surge of electrical activity affects a part or all of the brain.
Of the approximately 2.8 million people in the United States with epilepsy, it is estimated that about 175,000 experience cluster seizures, also known as acute repetitive seizures or bouts of increased seizure activity. These patients may experience cluster seizures even though they are receiving stable regimens of antiepileptic medications. Currently, many of these individuals default to emergency room care or no care at all, according to Acorda.