Eton to License Libervant Buccal Film for U.S. Launch
The exclusive U.S. license adds an orphan-designated seizure-rescue therapy and a neurology platform in a market Eton said exceeds $450 million annually.
Eton Pharmaceuticals, Inc. (ETON) agreed to an exclusive U.S. license for Libervant® (diazepam) buccal film, an orphan-designated seizure-rescue therapy, expanding its rare-disease portfolio into neurology and creating a new commercial platform in a U.S. market the company said exceeds $450 million annually.
The rare-disease company said the license is expected to close in April 2027, subject to final FDA approval.
“LIBERVANT marks an important expansion of our portfolio into neurology and represents a compelling opportunity to bring an orphan-designated, differentiated therapy to patients,” said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals.
Libervant is a buccally administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy. Aquestive developed the product as an alternative to device-based options for refractory epilepsy, including rectal gel and nasal spray.
U.S. market access has been constrained by orphan-drug exclusivity on an intranasal product. The FDA granted tentative approval in August 2022 for Libervant in patients 12 years of age and older. Access for that age group is currently subject to the expiration of that exclusivity, scheduled for January 2027.
An April 2024 FDA approval for patients between two and five years of age was later converted to a tentative approval after a court ruling that the FDA lacked authority to approve Libervant for that age band because of the same orphan exclusivity. Aquestive filed for FDA approval for patients aged 6 to 11 in the second quarter of 2026.
Eton’s expected April 2027 close sits after the January 2027 exclusivity date that has gated the 12-and-older indication, the window in which the company said it will take the U.S. license.