FDA approves diazepam for seizure clusters in patients 2 to 5 years


With the approval comes the immediate availability of 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg doses for patients between 2 to 5 years of age.

FDA approves diazepam for seizure clusters in patients 2 to 5 years | Image Credit: © Calin - © Calin - stock.adobe.com.

FDA approves diazepam for seizure clusters in patients 2 to 5 years | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has approved diazepam (Libervant Buccal Film; Aquestive Therapeutics) to treat intermittent, stereotypic episodes of frequent seizure activity, such as seizure clusters or acute repetitive seizures, in patients aged between 2 and 5 years1,2

The approval makes diazepam buccal film the first and only FDA approved, orally administered rescue product to treat seizure clusters in the indicated patient population. According to Aquestive, there is "immediate availability of 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg doses for patients between 2 to 5 years of age."1

"It provides a new option to treat seizure emergencies," Michael Rogawski, MD, professor of neurology and pharmacology, University of California Davis Health Medical Center, told our sister publication NeurologyLive®. 3

"This is a condition where a patient has an increase in seizure frequency, and there is a concern on the part of a caregiver that this unusual seizure pattern could lead to additional seizures and potentially to status epilepticus, which is a life-threatening seizure emergency," said Rogawski. "The intent of products like this is to inhibit the occurrence of additional seizures and prevent the deterioration of the patient to status epilepticus."3

Click here for additional commentary from Rogawski regarding the FDA approval of diazepam buccal film.

The buccally-administered film formation of diazepam was developed as an alternative to the device-based products available for epilepsy, including rectal gel and nasal spray products.2

Data from the poster session "Crossover Study Evaluating the Effect of Seizures on the Absorption of Diazepam From a Buccal Film Formulation in Children With Epilepsy," was presented at the 76th annual American Academy of Neurology Meeting (AAN) on April 17, 2024.5

According to an abstract from AAN, the objective of the crossover study was to compare plasma exposures from diazepam buccal film administered in children with epilepsy under periictal or interictal conditions.4,5

The study featured male and female children aged 2 to 16 years with refractory epilepsy. Individuals received diazepam buccal film at doses of 5.0 to 17.5 mg in an epilepsy monitoring unit setting. Twenty-four individuals received at least 1 dose of diazepam buccal film, of which 17 were in the interictal period and 16 in the periictal period.5

According to the abstract, there was no difference in median time to maximum diazepam concentration when patients were dosed in either seizure state, leading the authors to conclude that diazepam buccal film provided a convenient way to deliver diazepam to treat acute repetitive seizure emergencies in children.5

"When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options," said Daniel Barber, CEO, Aquestive in a press release when the New Drug Application (NDA) was accepted by the FDA in September 2023.2

"We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access," Barber added.2


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. Aquestive Therapeutics. April 29, 2024. Accessed April 29, 2024. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-receives-us-fda-approval-and-market

2. Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant (diazepam) Buccal Film in Pediatric Patients and Assignment of Prescription Drug User Fee Act (PDUFA) Date. Aquestive Therapeutics. Press release. September 11, 2023. Accessed April 25, 2024. https://aquestive.com/aquestive-therapeutics-receives-fda-acceptance-of-new-drug-application-nda-for-libervant-diazepam-buccal-film-in-pediatric-patients-and-assignment-of-prescription-drug-user-fee-act-pdufa/

3. Diazepam Buccal Film’s Role in Treating Intermittent Pediatric Seizures, with Michael Rogawski, MD. NeurologyLive. Accessed April 26, 2024. https://www.neurologylive.com/diazepam-buccal-film-role-treating-intermittent-pediatric-seizures-michael-rogawski

4. Aquestive Therapeutics To Present Crossover Study Data For Libervant (Diazepam) Buccal Film At 76th Annual Meeting Of The American Academy Of Neurology. Aquestive Therapeutics. Press release. April 12, 2024. Accessed April 25, 2024. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-present-crossover-study-data-libervanttm

5. Slatko G, Wargacki S, Rogawski M. Crossover Study Evaluating the Effect of Seizures on the Absorption of Diazepam from a Buccal Film Formulation in Children with Epilepsy. Mira Smart Conferences. PDF. Accessed April 25, 2024. https://index.mirasmart.com/AAN2024/PDFfiles/AAN2024-005193.html

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