UCB’s Nayzilam (midazolam) Receives FDA’s Approval for the Treatment of Seizure Cluster in Epilepsy in the US

Shots:

• The approval follows Study 1 consisting of two phases ie, Test Dose Phase & Comparative Phase assessing Nayzilam (midazolam) vs PBO in 292 & 201 patients with intermittent, stereotypic episodes of frequent seizure activity aged ≥12yrs. respectively
• The Study 1 results: termination of seizures within 10 min after initial dose (80.6% vs 70.1%); absence of seizure recurrence b/w 10min & 6hrs. after the initial dose (58.2% vs 37.3%); an occurrence of seizures within 24hrs. after the initial blinded dose (37.3% vs 46.3%); longer time to next seizure than PBO
• Nayzilam (midazolam) nasal spray CIV, designed as single-use treatment, allowing the non-healthcare professionals to administer the drug in patients actively seizing when and where a seizure cluster occurs, UCB acquired Nayzilam from Proximagen in Jun’18 for $370M

Click here to read full press release/ article | Ref: UCB | Image: Pharmaceutical Technology