29 May NAYZILAM® (midazolam) Nasal Spray Approved To Treat Seizure Clusters
MedicalResearch.com Interview with:
Dr. Steven S. Chung, MD
Executive Director and Program Chair
Neuroscience Institute and Director of the Epilepsy Program
Banner – University Medical Center
MedicalResearch.com: What is the background for this study? How is Nayzilam different from other treatments for epilepsy? Who/How is it administered?
Response: NAYZILAM is the first medication and only FDA-approved nasal option for treating seizure clusters. NAYZILAM allows for administration by a non-healthcare professional to patients when a seizure cluster occurs, which could provide significant value to patients who currently have limited treatment options for SC.
The effectiveness of NAYZILAM was established in a randomized, double-blind, placebo-controlled trial (Study 1; NCT 01390220).
Study 1 was conducted in two phases: an open-label Test Dose Phase followed by a randomized, double-blind, placebo-controlled, Comparative Phase. In the Test Dose Phase, tolerability was assessed in 292 patients. Patients were excluded from participation in the Comparative Phase if they failed to meet pre-defined blood pressure, heart rate, sedation, electrocardiogram, and peripheral oxygen saturation criteria. In the Comparative Phase, 201 patients treated a single seizure cluster episode in an outpatient setting.
Numerical differences in favor of NAYZILAM were observed on each of the components of the treatment success responder definition; termination of seizure(s) within 10 minutes after initial dose of study drug (80.6 versus 70.1%) and the absence of seizure recurrence between 10 minutes and 6 hours after the initial dose of study drug (58.2 versus 37.3%).
Study 1 also evaluated the occurrence and time to next seizure after the initial blinded dose of study drug. A smaller proportion of NAYZILAM-treated patients experienced the next seizure within 24 hours after the initial blinded dose of study drug (37.3% versus 46.3%). NAYZILAM-treated patients experienced a statistically longer time-to-next-seizure than the placebo group.
MedicalResearch.com: What should readers take away from your report?
Response: We know from research that more than 150,000 people in the U.S. with uncontrolled epilepsy also experience seizure clusters. And, despite the impact of seizure clusters, many diagnosed patients may go untreated because currently available treatment options are limited. Rescue treatment of seizure clusters is critical because when left untreated, seizure clusters can increase the risk of physical injury, neurological damage, prolonged seizures, and status epilepticus.
As the first new medication approved to treat seizure clusters in more than 20 years in the U.S., NAYZILAM will provide significant value to patients who need additional options that are more convenient, non-invasive and easily administered by a caregiver.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: As a neurologist specializing in epilepsy, I have seen firsthand how seizure clusters can have a significant impact on the quality of life of a person with epilepsy. The availability of a new treatment option, such as Nayzilam (midazolam), has the potential to improve the lives of patients and their families by providing another option for rescue care.
UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.
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