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, Inc. announced the FDA has approved Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy between 2 to 5 years of age
“We are thrilled to have received FDA approval for Libervant in patients between the ages of two and five,” said Daniel Barber, Chief Executive Officer of Aquestive. “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.”
“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, M.D., Ph.D, distinguished professor of neurology and pharmacology, University of California, Davis, “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.”
In 2023, over 55,000 prescriptions were filled for patients between the ages of 2 and 5. This was an increase of 10.8% over the previous year and an average increase of 9.3% over the last three years for this patient population. Over 90% of filled prescriptions in 2023 for this patient population were for diazepam rectal gel. Prescription writing for this indication is highly concentrated among pediatric epileptologists and pediatric neurologists.
The Company’s Anaphylm (epinephrine) Sublingual Film clinical development program remains on track. The Company is currently in the clinic completing the remaining studies required for the submission of the New Drug Application (NDA) for Anaphylm, which is planned for the end of 2024. The Company will provide a more detailed update on Anaphylm at its upcoming first quarter 2024 earnings call on May 8, 2024.
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