Eton Pharmaceuticals, Inc. (ETON) and Aquestive Therapeutics, Inc. (AQST) announced an exclusive US licensing and supply agreement Wednesday for LIBERVANT, a treatment for seizure clusters in patients with epilepsy.
Under the agreement, Eton will gain exclusive US commercialization rights to LIBERVANT, a diazepam film that dissolves inside the cheek.
The treatment offers an alternative to existing nasal sprays and rectal medications used to manage seizure clusters.
Eton expects to launch LIBERVANT in April 2027, subject to final approval from the US Food and Drug Administration.
Expansion Into Neurology
The agreement marks Eton's expansion into neurology and adds a potential growth opportunity to its rare disease portfolio.
Eton CEO Sean Brynjelsen said the US seizure rescue market exceeds $450 million annually. He expects the treatment to benefit from Eton's specialty drug commercialization experience and patient support programs.
Meanwhile, Aquestive CEO Daniel Barber said the partnership combines the company's drug delivery technology with Eton's commercial infrastructure to expand treatment options.
Eton also plans to establish a dedicated neurology team to support the launch.
FDA Approval Timeline
The FDA granted LIBERVANT orphan drug designation in November 2016. The treatment currently holds tentative approval for patients ages 2 to 5 and those 12 and older.
LIBERVANT could become eligible for full approval for patients 12 and older after VALTOCO's orphan drug exclusivity expires Jan. 10, 2027.
Additionally, the FDA is reviewing an application to expand LIBERVANT's label to include children ages 6 to 11. The agency has set a March 29, 2027, decision deadline.
The treatment has patent protection extending into 2038, with additional applications pending.
Patient Research Supports Demand
In a survey of 101 patients, 71% preferred buccal film over nasal spray, compared with 13% favoring nasal spray, assuming equal effectiveness.
Separately, 76% expressed concern about lacking immediate access to seizure medication while away from home. However, only 34% reported always carrying it.
The findings reflect patient preferences rather than proven differences in clinical effectiveness.
Price Action: Eton Pharmaceuticals shares were up 0.10% at $53.38 and Aquestive Therapeutics shares were down 0.64% at $4.63 at the time of publication on Wednesday, according to market data.
