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

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

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  • 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

Ref: UCB | Image: Pharmaceutical Technology

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