FDA OKs Midazolam Nasal Spray for Treating Intermittent Epileptic Seizures

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.

Reference

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.
 



Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 


Related Articles

Cohesion among key stakeholders, which will lead to an evolution in care, is clearly on the rise, and the growth of those relationships will only benefit patients in the end.
The annual Asembia Specialty Pharmacy Summit has become the largest meeting in the specialty space, and this year it exceeded prior numbers in attendance and offerings in programing.
With drug pricing increasingly becoming a hot button issue and greater consternation surrounding the cost of treating a chronic disease among the general public, it is clear that the health care industry is at a crossroads.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Advertise
Careers
Contact Us
Terms & Conditions
Privacy
MJH Associates >
Pharmacy Times
OTCGuide
American Journal of Managed Care
Cure
MD Magazine
ONCLive
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.
 

$vacMongoViewPlus$