FDA Approves Aquestive Therapeutics’ Libervant for the Treatment of Seizure Clusters in Children Aged 2 to 5 Years

Image Credit: Adobe Stock Images/Justlight

Aquestive Therapeutics announced that the FDA has officially approved Libervant (diazepam) Buccal Film to treat seizure clusters in children aged two to five years. According to the company, the film works by being applied inside the cheek, where it naturally dissolves and provides a steady dose of diazepam. Currently, most prescriptions are being prepared, with Medicaid expected to be added at a later date. Libervant is the first and only FDA-approved orally administered rescue medication for seizures in this age group.¹

“We are thrilled to have received FDA approval for Libervant in patients between the ages of two and five,” said Daniel Barber, CEO, Aquestive, in a press release. “Patients have been waiting years for Libervant, the first and only FDA approved orally-administered rescue product for the treatment of seizure clusters. Our first priority is to provide and maintain availability of Libervant to the intended patient population. I am pleased to announce that we are currently able to accept and fill non-Medicaid prescriptions. We expect to expand our distribution capabilities over the coming weeks and months. I am also pleased with our continued track record of success with the FDA. We respect the FDA’s mission to protect public health and we will always seek to partner with the FDA wherever possible.”

Earlier this month, Aquestive presented data from Libervant for the aforementioned age group at the 76th Annual Meeting of the American Academy of Neurology.²

“This study underscores our ongoing dedication to enhancing the well-being of individuals battling epilepsy,” said Barber, in a press release. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy between ages two to five, we believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population.”

According to data from the Centers for Disease Control and Prevention, around 470,000 children suffer from epilepsy globally.3 The Epilepsy Foundation states that the condition can have a significant social impact in childhood, resulting in isolation and loss of self-esteem. In some scenarios, it could be a temporary condition that could be solved with a few years of medication; however, it is often a lifelong condition for many others.⁴

Aquestive reported that last year, over 55,000 prescriptions were filled for patients aged two to five years for treating epilepsy, up 10.8% from 2022 statistics.¹

“Libervant provides a new way to deliver diazepam for the treatment of acute repetitive seizure emergencies in children aged two to five,” said Michael Rogawski, MD, PhD, professor of neurology and pharmacology, University of California, Davis, in the press release. “The film is placed onto the buccal mucosa inside the cheek where it adheres firmly and dissolves quickly, delivering a consistent dose of diazepam. Studies show that the film is easy to administer and performs reliably in children as young as 2 years of age. Libervant is packaged in a compact foil pouch that is convenient to carry so that the treatment can be available wherever these children may be.”

References

1. Aquestive Therapeutics Receives U.S. FDA Approval and Market Access for Libervant™ (diazepam) Buccal Film in Pediatric Patients Ages 2 to 5 and Provides Update on Anaphylm™ (epinephrine) Sublingual Film. GlobeNewswire. April 29, 2024. Accessed April 29, 2024. https://www.globenewswire.com/news-release/2024/04/29/2871087/0/en/Aquestive-Therapeutics-Receives-U-S-FDA-Approval-and-Market-Access-for-Libervant-diazepam-Buccal-Film-in-Pediatric-Patients-Ages-2-to-5-and-Provides-Update-on-Anaphylm-epinephrine-.html

2. Aquestive Therapeutics to Present Crossover Study Data for Libervant™ (diazepam) Buccal Film at 76th Annual Meeting of the American Academy of Neurology. GlobeNewswire. April 12, 2024. Accessed April 29, 2024. https://www.globenewswire.com/fr/news-release/2024/04/12/2862377/0/en/Aquestive-Therapeutics-to-Present-Crossover-Study-Data-for-Libervant-diazepam-Buccal-Film-at-76th-Annual-Meeting-of-the-American-Academy-of-Neurology.html

3. Epilepsy Fast Facts. CDC. Accessed April 29, 2024. https://www.cdc.gov/epilepsy/about/fast-facts.htm#:~:text=Active%20Epilepsy&text=This%20is%20about%203.4%20million,million%20adults%20and%20470%2C000%20children.&text=According%20to%20the%20latest%20estimates,17%20years%20have%20active%20epilepsy.&text=Think%20of%20a%20school%20with,of%20them%20could%20have%20epilepsy.

4. Epilepsy in Childhood. Accessed April 29, 2024. https://www.epilepsy.com/parents-and-caregivers/kids