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 US.
- NAYZILAM® (midazolam) nasal spray CIV is a nasally administered benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., 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.
- NAYZILAM allows for administration by a non-healthcare professional in patients actively seizing when and where a seizure cluster occurs.
- Approval of NAYZILAM adds to UCB’s already existing anti-epilepsy drug portfolio, reinforcing the company’s position as a global leader in epilepsy.
UCB announced the FDA has approved a New Drug Application for the company’s newest anti-epileptic drug (AED) NAYZILAM® (midazolam) nasal spray CIV, a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., 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. NAYZILAM now provides patients and caregivers with the first and only FDA-approved nasal option for treating seizure clusters.
It is estimated that more than 150,000 people in the US with uncontrolled epilepsy also experience seizure clusters.1 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.2 Despite the impact of seizure clusters, many diagnosed patients may go untreated because currently available treatment options are not preferred.3, 4, 5, 6
NAYZILAM is a short-term treatment for seizure clusters in patients with epilepsy. The nasal spray is designed as a single-use treatment that can be carried with a patient. NAYZILAM allows for administration by a non-healthcare professional in patients actively seizing when and where a seizure cluster occurs. NAYZILAM can provide value to patients who are experiencing these disruptive seizures.
2 Penovich PE, Buelow J, Steinberg K, Sirven J, Wheless J. Burden of seizure clusters on patients with epilepsy and caregivers: survey of patient, caregiver, and clinician perspectives. Neurologist. 2017;22(6):207-214.
3 Nunley S, Glynn P, Rust S, Vidaurre J, Albert DVF, Patel AD. A hospital-based study on caregiver preferences on acute seizure rescue medications in pediatric patients with epilepsy: intranasal midazolam versus rectal diazepam. Epilepsy Behav. 2019;92:53-56.
4 Holsti M, Dudley N, Schunk J, et al. Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. Arch Pediatr Adolesc Med. 2010;164(8):747-753.
5 de Haan GJ, van der Geest P, Doelman G, Bertram E, Edelbroek P. A comparison of midazolam nasal spray and diazepam rectal solution for the residential treatment of seizure exacerbations. Epilepsia. 2010;51(3):478-482
6 Bhattacharyya M, Kalra V, Gulati S. Intranasal midazolam vs rectal diazepam in acute childhood seizures. Pediatr Neurol. 2006;34(5):355-359.