UCB has received FDA approval for Nayzilam® (midazolam) nasal spray CIV, a benzodiazepine for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients aged 12 years and older. Midazolam now offers patients and caregivers the first and only FDA-approved nasal treatment for seizure clusters.
More than 150,000 people in the U.S. with uncontrolled epilepsy are estimated to experience seizure clusters. Left untreated, they can increase the risk of physical injury, neurological damage, prolonged seizures, and status epilepticus, making rescue treatment vital. Despite the impact of seizure clusters, many diagnosed patients may go untreated if currently available treatment options are not appropriate.
Midazolam nasal spray is a single-use treatment that patients can carry with them, which can be used by a non-health care professional whenever a seizure cluster occurs. The nasal delivery could prove invaluable to patients who currently have limited treatment options.
The effectiveness of midazolam for the acute treatment of seizure clusters or acute repetitive seizures that are distinct from a patient’s usual seizure pattern, in patients with epilepsy aged 12 years and older, was established in the randomized, double-blind, placebo-controlled Study 1, NCT01390220.
Study 1 enrolled 201 patients with epilepsy on a stable regimen of antiepileptic drugs with intermittent, stereotypic episodes of frequent seizure activity distinct from their usual seizure pattern.
The primary efficacy endpoint was termination of seizures within 10 minutes after the initial blinded dose of midazolam and the absence of seizure recurrence within six hours of the initial dose. A statistically significantly higher percentage of midazolam-treated patients met the primary efficacy endpoint compared with placebo patients.
The most common adverse reactions were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea.
Serious cardiorespiratory adverse reactions have been observed after administration of midazolam. Patients and caregivers should be informed of the risks of respiratory depression and cardiac and respiratory arrest.
Source: UCB, May 20, 2019