Starting December 2, midazolam (Nayzilam, UCB) will be available at retail pharmacies for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patientâ€™s usual seizure pattern with epilepsy.
Starting December 2, midazolam (Nayzilam, UCB) will be available at retail pharmacies for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern with epilepsy.1
According to UCB, midazolam is the first and only rescue nasal treatment approved by the FDA to treat seizure clusters in the United States. Midazolam was given a New Drug Application approval by the FDA in May.2
Through a randomized, double-blind, placebo-controlled trial, Study 1: NCT01390220, midazolam was tested for effectiveness and tolerability in 292 patients. The participants each received 10 mg of midazolam over a course of 10 minutes.1
In a comparative phase, 201 patients were treated in a single seizure cluster in an outpatient setting with either a blind 5 mg dose of midazolam (134 patients) or placebo (67 patients). Patients in both groups had the option to receive a subsequent unblinded dose of midazolam 5 mg to be used between 10 minutes and 6 hours after administration of the original blinded dose of the drug.1
The midazolam treatment showed success with a termination of seizures within 10 minutes after the initial blinded dose of the study drug. In addition, there was an absence of a recurrence of seizures within 6 hours of the initial blinded dose of the study drug.1
Midazolam nasal spray is designed as a single-use treatment that can be carried with a patient and allows for administration by a non-health care professional when a seizure cluster occurs. Its nasal delivery could provide significant value to patients who currently have limited treatment options.2
Adverse reactions analyzed in the trial included somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea. Other reactions from the administration of midazolam may include respiratory depression, cardiac and respiratory arrest, central nervous system (CNS) depressant effect, and more.1