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 - Seite 2

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.

Conference Call and Webcast Reminder
The Company will host a conference call at 8:00 a.m. ET on Monday, April 29, 2024.

In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin.

A live webcast of the call will be available on Aquestive’s website: FDA Approval for Libervant Investor Call. The webcast will be archived for 30 days.

About Libervant
Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended 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 2 to 5 years of age. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA granted tentative approval in August 2022 for Libervant for treatment of these epilepsy patients 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. The FDA approval for U.S. market access received in April 2024 for Libervant is for these epilepsy patients between two and five years of age.