Eton Pharmaceuticals and Aquestive Therapeutics have signed an exclusive U.S. licensing and supply agreement for Libervant, a diazepam buccal film for seizure clusters, setting up a commercial launch targeted for April 2027.
The deal gives Eton exclusive U.S. commercialization rights for Libervant and expands its rare-disease portfolio into neurology. Eton said the seizure rescue market in the U.S. exceeds $450 million annually.
Libervant already has tentative FDA approval for patients ages 2 to 5 and 12 and older, with full approval for patients 12 and older expected after Valtoco’s orphan-drug exclusivity expires on Jan. 10, 2027. A separate NDA seeking to add ages 6 to 11 is under FDA review, with a PDUFA date of March 29, 2027. If approved, that filing would broaden the labeled population to ages 6 and up.
Patient research in 101 surveyed patients showed 76% were somewhat or highly concerned about not having their medication within arm’s reach when away from home, while only 34% said they always carry it outside the home. In a packaging comparison, 71% preferred or strongly preferred the film version for their physician to prescribe, versus 13% for nasal spray, assuming equal efficacy.
Libervant carries orphan-drug designation and patent protection extending into 2038, with additional patent applications still pending. Eton said it expects the product to be commercially available in April 2027, pending final FDA approval. The market has reacted to these announcements by moving the company's shares -3.48% to a price of $53.33. Check out the company's full 8-K submission here.
