“Because the nasal diazepam might be FDA approved, that is the difference between getting insurance coverage for it or not. It hasn’t happened yet, but that’s the hope... It will become more accessible and more insurance will provide coverage for it.”

Data previously presented at the 2019 Child Neurology Society annual meeting demonstrated intranasal diazepam’s (Valtoco; Neurelis) safety and tolerability in the treatment of cluster or acute, repetitive seizures in pediatric patients with epilepsy. While rectal diazepam is currently approved for this indication, Neurelis awaits a decision by the FDA to bring its novel intranasal delivery system to market, with the hopes that an approval will grant patients more autonomy to treat seizure clusters with a more comfortable and accessible mode of administration.  

In an interview with NeurologyLive at the 2019 American Epilepsy Society Annual Meeting, Ian Miller, MD, medical director of the Comprehensive Epilepsy Clinic at Nicklaus Children’s Hospital in Miami, Florida, spoke about the advantages that an intranasal formulation present over current formulations and available treatments. Neurelis expects a decision from the FDA before the end of the year.

To learn more about the drug candidate and understand why there is such a need for a new treatment option, NeurologyLive spoke with Miller at AES 2019, where he emphasized the potential impact the drug can have if it becomes FDA-approved.

For more coverage of AES 2019, click here.