Special Episode: FDA Approval of Diazepam Buccal Film for Pediatric Seizures
May 01, 06:00 PM
Welcome to this special episode of the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. For major FDA decisions in the field of neurology, we release short special episodes to offer a snapshot of the news, including the main takeaways for the clinical community, as well as highlights of the efficacy and safety profile of the agent in question.
In this episode, we're covering the recent approval of diazepam buccal film (Libervant; Aquestive Therapeutics) for the treatment of pediatric patients with intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures). Indicated for those between 2 and 5 years of age, the therapy offers patients a compact, easily administered diazepam formulation. The FDA previously granted tentative approval in August 2022 for Libervant for treatment of these patients with epilepsy 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. Following the approval, Michael Rogawski, MD, PhD, a distinguished professor of neurology and pharmacology at the University of California Davis Health Medical Center, provided insight on what the decision means for patients and clinicians. Rogawski gave comment on the significance of having a new administration route for diazepam, the safety and feasibility of diazepam buccal film, and some of the major points of emphasis from its clinical program.
In this episode, we're covering the recent approval of diazepam buccal film (Libervant; Aquestive Therapeutics) for the treatment of pediatric patients with intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures). Indicated for those between 2 and 5 years of age, the therapy offers patients a compact, easily administered diazepam formulation. The FDA previously granted tentative approval in August 2022 for Libervant for treatment of these patients with epilepsy 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. Following the approval, Michael Rogawski, MD, PhD, a distinguished professor of neurology and pharmacology at the University of California Davis Health Medical Center, provided insight on what the decision means for patients and clinicians. Rogawski gave comment on the significance of having a new administration route for diazepam, the safety and feasibility of diazepam buccal film, and some of the major points of emphasis from its clinical program.
For more of NeurologyLive's and Contemporary Pediatrics coverage of diazepam buccal film's approval, head here: FDA approves diazepam for seizure clusters in patients 2 to 5 years
Episode Breakdown:
- 0:20 – Diazepam buccal film approved for intermittent seizures in pediatrics
- 2:00 – Michael Rogawski, MD, PhD, giving reaction to the approval
- 4:10 – Flexibility with multiple diazepam administration routes
- 6:55 – Rogawski on the safety of diazepam buccal film amid high need
- 12:30 – Notable takeaways from the diazepam buccal film trial program
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