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UCB Announces availability of NAYZILAM® (midazolam) Nasal Spray CIV for Seizure Clusters in the US

November 25, 2019

UCB announced today that NAYZILAM® (midazolam) nasal spray CIV will be available in retail pharmacies on December 2, 2019, 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.1

NAYZILAM is the first and only rescue nasal treatment approved to treat seizure clusters in the U.S. NAYZILAM is a ready-to-use solution that can be used when and where a seizure cluster occurs and can be administered by a non-healthcare professional to a patient during or after a seizure within a cluster.1 As with all benzodiazepines, including NAYZILAM, concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.1

“Delivering another of the six potential new product launches, a UCB mission over the next five years, NAYZILAM builds on UCB’s commitment to addressing the unmet needs of people living with epilepsy,” said Mike Davis, Head of Neurology in the U.S., UCB.  “For the first time, people 12 years and older now have a nasally administered rescue therapy shown to help manage seizure clusters. NAYZILAM can be administered anywhere seizure clusters strike, allowing families to take back valuable moments that would otherwise be lost.”

It is estimated that more than 150,000 people in the U.S. with uncontrolled epilepsy also experience seizure clusters.2-4 Rescue treatment of seizure clusters is critical because when left untreated, seizure clusters can increase the risk of physical injury, neurological damage, and status epilepticus.5-8 Despite the impact of seizure clusters, many diagnosed patients may go untreated because currently available treatment options are not preferred.9-12 Currently, only one in five people living with seizure clusters report using a rescue treatment.5 Many patients seek care in the emergency department.5

“Seizure clusters are a medical emergency that can have very serious consequences for those living with them,” said Dr. Laura Lubbers, Chief Scientific Officer, Citizens United for Research in Epilepsy (CURE). “An effective seizure cluster rescue treatment, like NAYZILAM, that is convenient and easily administered, along with a seizure cluster action plan, can change the lives of people living with seizure clusters and their families.”

The approval of NAYZILAM was based on a placebo-controlled trial, with a primary efficacy endpoint of treatment success, defined by 2 components: 1) seizure termination within 10 minutes and 2) no seizure recurrence within 6 hours.1 NAYZILAM helped the majority of patients stop a seizure cluster fast and helped patients return to baseline function in approximately 90 minutes.1,13 The most common adverse reactions (greater than or equal to 5% in any NAYZILAM treatment group) were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea.1   Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours.1

UCB is committed to finding solutions for patients with unmet needs, including people living with seizure clusters. NAYZILAM builds on UCB’s long-standing leadership in epilepsy and commitment to enabling patients to live their best lives.
It is anticipated that NAYZILAM prescriptions will cost commercial patients $40 per box.13 Each box contains two doses.1 With the NAYZILAM Savings Card, eligible patients could pay $20 per box.13

For additional medical information about NAYZILAM, patient assistance, or any other information please visit NAYZILAM.com or call ucbCARES® at 1-844-599-2273. Full affordability information can be found at UCBUSA.news/Affordability.