Deer Park, Illinois-based Eton Pharmaceuticals (Nasdaq: ETON) entered into an exclusive license agreement with New Jersey-based Aquestive Therapeutics, Inc. (Nasdaq: AQST) for exclusive U.S. commercialization rights to LIBERVANT (diazepam) buccal film, a treatment for seizure clusters in patients with epilepsy. Financial terms were not disclosed. Aquestive is eligible to receive upfront, milestone, and royalty payments and retains manufacturing and supply responsibilities under a separate supply agreement.
Libervant currently holds tentative US FDA approval for patients aged 2–5 and those aged 12 and older. Its April 2024 approval for the younger group was subsequently converted to tentative approval following a court ruling concerning competing diazepam nasal spray Valtoco’s orphan drug exclusivity.
The companies said Libervant would become eligible for full approval in patients aged 12 and older after Valtoco’s exclusivity is scheduled to expire on January 10, 2027. A separate application covering ages 6–11 is under review, with a target decision date of March 29, 2027. Eton anticipates an April 2027 launch, subject to final US FDA approval.