FDA Rejects Plumiaz (Diazepam) Nasal Spray for Epilepsy Seizures
Agency approval doubtful this year
The FDA has issued a complete response letter (CRL) regarding the new drug application (NDA) for Plumiaz (diazepam) nasal spray for the treatment of patients with epilepsy who experience cluster seizures.
A CRL is a communication from the FDA that informs a company that its review of the NDA is complete, and that the application cannot be approved in its present form.
The product’s developer (Acorda Therapeutics) does not expect Plumiaz to receive FDA approval in 2014.
Of the approximately 2.8 million people in the U.S. with epilepsy, it is estimated that approximately 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 generally are receiving stable regimens of antiepileptic medications. Many of these individuals do not find the currently available outpatient therapy acceptable and default to emergency room care or no care at all.
Rectally administered diazepam is the only outpatient treatment approved by the FDA for patients with epilepsy who experience cluster seizures.
Plumiaz was granted “orphan drug” status from the FDA in July 2012. The product’s NDA was submitted for review in 2013.
Source: Acorda Therapeutics; May 2, 2014.