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

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