Biopharmaceutical company UCB revealed on Monday the receipt of approval from the US Food and Drug Administration (FDA) for the New Drug Application for the new anti-epileptic drug (AED) (midazolam) nasal spray CIV for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in epilepsy patients.
Based in Brussels, Belgium, the company added that the US FDA has approved the new anti-epileptic drug (AED) (midazolam) nasal spray CIV for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. Epilepsy is a chronic neurological disorder of the brain.
According to the company, NAYZILAM now provides patients and caregivers with the first and only US FDA-approved nasal option for treating seizure clusters.The 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.
ANAYZILAM, a benzodiazepine, is the first new medication approved to treat seizure clusters in more than 20 years in the US. The nasal spray is designed as a single-use treatment that can be carried with a patient. It allows for administration by a non-healthcare professional in patients seizing when and where a seizure cluster occurs, disclosed the company.
In conjunction, the US FDA approval of ANAYZILAM was based on the company's Study 1 that was conducted in two phases: an open-label Test Dose Phase followed by a randomized, double-blind, placebo-controlled, Comparative Phase. The primary efficacy endpoint for Study 1 was treatment success, defined as the termination of seizures within ten minutes after the initial blinded dose of study drug and the absence of a recurrence of seizures within six hours of the initial blinded dose of study drug.
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