UCB SA announced that Epilepsy & Behavior published a post hoc analysis from the Phase 3 open-label extension study of NAYZILAM. This analysis showed the estimated median time to RTFBF, regardless of treatment with one or two doses, was 90 minutes. While most patients required a single 5-mg spray to treat the cluster, patients and caregivers had the option to administer a second 5-mg dose after only 10 minutes if needed.

This publication characterized the impact of one or two doses on the time to RTFBF. The Phase 3 open-label extension (OLE) study evaluated the safety of repeated, intermittent use of NAYZILAM in individuals living with epilepsy experiencing acute repetitive seizures, also known as seizure clusters. Patients were followed for a median of 17 months and 7 treated seizure clusters per patient.

The use of a second dose did not increase over treated cluster episodes. The post hoc analysis represents 1,996 treated seizure cluster episodes in 161 patients. NAYZILAM 5-mg was administered by a caregiver when a patient experienced a seizure cluster.

Another 5-mg dose could be given if the seizure did not terminate within 10 minutes or if there was seizure recurrence within 6 hours. Results showed the median time to RTFBF was similar in patients treated with either one or two doses of NAYZILAM (approximately 30% within 30 minutes, and nearly 50% within 1 hour), suggesting that the dose of NAYZILAM does not influence the RTFBF. In the study, 97.2% of patients treated with one dose and 94.2% of patients treated with two doses experienced RTFBF within 24 hours of administration.

Additionally, 45.9% of patients treated with one dose and 44.7% of patients treated with two doses of NAYZILAM experienced RTFBF within 1 hour of administration. Seizure clusters are episodes of frequent seizure activity that are distinct from a person's usual seizure pattern.2 They can be triggered by missed doses or changes in medication, menstrual cycles, and stress, among other factors. If left untreated, seizure clusters can result in emergency room visits or potentially more serious consequences, including status epilepticus and death.4,5 Three out of four people living with epilepsy live in fear of having their next seizure cluster.6 The time it takes to recover physically and cognitively following a seizure cluster can negatively impact a person's quality of life, including their ability to go to school or work, or participate in social activities.