James Wheless, MD: Treating Seizure Clusters With Midazolam

“We’ve always known that we needed a treatment for seizure clusters at home and the key was trying to develop a product that would do what we wanted it to do—that it was safe, but would also interrupt the seizure cluster—and was one that the patient could use at home. Nayzilam represents an option that fills all of those criteria.”

In May 2019, the FDA approved midazolam (Nayzilam; UCB) the first nasal spray for the treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from usual seizure patterns in patients with epilepsy 12 years of age and older. Its regulatory go-ahead marked an important moment for this patient population, whose prior options were drastically limited. It became commercially available in December 2019.

The benzodiazepine, which may be administered in the outpatient setting by a non-healthcare professional in patients actively seizing and where a seizure cluster occurs, is supplied as 2 single-use nasal spray units, each containing a 5 mg dose of midazolam in 0.1 mL solution. Its effectiveness of midazolam was established in a phase 3 randomized, double-blind, placebo-controlled trial (NCT01390220) that was conducted in 2 phases: an open-label test dose phase followed by a comparative phase.

At the 73rd annual meeting of the American Epilepsy Society (AES), December 6-10, 2019, in Baltimore, Maryland, NeurologyLive sat down with James Wheless, MD, professor and chief, pediatric neurology, and director, comprehensive epilepsy program and neuroscience institute, Le Bonheur Children’s Hospital, to discuss the therapy and its potential impact further. He offered insight into his experience with midazolam in clinical trials, as well as the debilitating nature of seizure clusters and the critical need which this product has the opportunity to fill.

For more coverage of AES 2019, click here.