The drug is indicated for seizures that are distinct from a patient's usual seizure pattern, in individuals age 12 years and older with epilepsy.
Officials with the FDA have approved a New Drug Application for UCB’s midazolam (Nayzilam) nasal spray CIV, an antiepileptic drug (AED) for treating intermittent, stereotypic episodes of frequent seizure activity, according to the company.
The drug is indicated for seizures that are distinct from a patient's usual seizure pattern, in individuals age 12 years and older with epilepsy. According to UCB, this midazolam nasal spray CIV provides patients and caregivers with the first and only FDA-approved nasal option for treating seizure clusters, and is the first new medication approved to treat seizure clusters in more than 20 years in the United States.
An estimated 150,000 or more people in the United States with uncontrolled epilepsy are affected by seizure clusters. Left untreated, seizure clusters can increase the risk of physical injury, neurological damage, prolonged seizures, and status epilepticus, according to UCB, and many diagnosed patients with may go untreated when preferred treatment options are unavailable.
"As global leaders in epilepsy, the approval of Nayzilam complements our already strong epilepsy portfolio, improving our ability to provide value to people living with poorly controlled seizures, and builds on our passion and expertise in this field. We are pleased to expand and diversify the solutions we can offer to the epilepsy community, providing an innovative and differentiated solution to help support management of seizure clusters," said Jean-Christophe Tellier, Chief Executive Officer, UCB, in a prepared statement.
Midazolam nasal spray is designed as a single-use treatment that can be carried with a patient and allows for administration by a non-health care professional when a seizure cluster occurs. Its nasal delivery could provide significant value to patients who currently have limited treatment options.
"When a patient experiences seizure clusters, there is often significant impact on their overall quality of life, in addition to posing greater risks for increased emergency department related hospitalizations and more serious seizure emergencies," said Dr. Steven S. Chung, MD, Executive Director and Program Chair of the Neuroscience Institute and Director of the Epilepsy Program at Banner — University Medical Center, in a prepared statement.
"Further, as a neurologist specializing in epilepsy, treating seizure clusters today presents a challenging barrier for many patients. The availability of a new treatment option, such as Nayzilam, has potential to help improve the lives of patients and their families by providing another option for rescue care,” Chung added.
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 U.S. [news release]. Brussels, Belgium and Atlanta, GA; May 20, 2019: UCB. https://prnmedia.prnewswire.com/news-releases/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-300852851.html. Accessed May 20, 2019.