James Wheless, MD: Treating Seizure Clusters With Midazolam скачать в хорошем качестве

James Wheless, MD: Treating Seizure Clusters With Midazolam

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 pattern 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 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.