Eton Pharmaceuticals (Nasdaq: ETON) and Aquestive Therapeutics (Nasdaq: AQST) have entered into an exclusive U.S. licensing and supply agreement for Libervant (diazepam) buccal film, a treatment for seizure clusters in epilepsy patients, according to a joint press release dated Oct. 14, 2026.

Under the agreement, Eton receives exclusive U.S. commercialization rights to Libervant, a buccal film that dissolves inside the cheek without a delivery device. The product carries Orphan Drug Designation and has tentative FDA approval for patients ages 2 to 5 and 12 and older. A separate application to expand the label to include patients ages 6 to 11 carries a PDUFA target date of March 29, 2027. Eton anticipates a commercial launch in April 2027, subject to final FDA approval.

Full approval for patients 12 and older is expected to become eligible following the scheduled expiration of Valtoco's orphan drug exclusivity on Jan. 10, 2027. Libervant holds issued patent protection through 2038, with additional applications pending.

Eton plans to build a dedicated neurology sales team supported by its existing commercial infrastructure. The company previously launched specialty medicines including Increlex, Galzin, and Hemangeol.

A third-party survey of 101 patients found that 71% preferred or strongly preferred buccal film over nasal spray, compared with 13% who preferred nasal spray, assuming equivalent efficacy. The release noted these results reflect stated preferences and not comparative clinical outcomes. The U.S. seizure rescue market is described in the release as exceeding $450 million annually.

"By pairing Aquestive's proprietary technology with Eton's commercial capabilities and patient support services, we aim to provide physicians, patients, and caregivers an additional treatment option," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

Aquestive CEO Daniel Barber said the collaboration "provides a focused path to U.S. commercialization" for the epilepsy community.