Nayzilam Approved to Treat Epilepsy
May 19, 2019 – The U.S. FDA has approved Nayzilam® (midazolam) nasal spray, manufactured by UCB, to provide acute treatment for intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. It is approved for use in patients who are at least 12 years of age and have epilepsy. A benzodiazepine, Nayzilam is the first nasal product to receive FDA approval for this indication.
In a clinical trial, a higher percentage of patients treated with Nayzilam (53.7%) achieved treatment success than those who received a placebo (34.3%). Treatment success was defined as the termination of seizures within 10 minutes after the initial dose and no recurrence of seizures within six hours of the initial dose. Of those patients who received Nayzilam, 37.3% experienced a seizure within 24 hours of the initial dose versus 46.3% of patients who received the placebo.
Caregivers are able to administer Nayzilam once they have received proper training from a healthcare provider. Recommended dosing is one 5mg spray in one nostril. If the patient has not responded to the initial dose within 10 minutes, a second 5mg spray can be administered in the opposite nostril. No more than two doses should be used to treat a seizure cluster. It is not recommended to use Nayzilam to treat more than one episode every three days or five episodes per month. A black box warning cautions that concomitant use of benzodiazepines and opioids can cause profound sedation, respiratory depression, coma, and death.
First approved in 1985, the active ingredient of Nayzilam is already available on the U.S. market in both oral syrup and injectable dosage forms. UCB has not yet announced launch or pricing plans for the nasal spray.