Eton Pharmaceuticals and Aquestive Therapeutics Announce Exclusive U.S. Licensing Agreement for LIBERVANT® (diazepam) Buccal Film
Key Highlights
- ➤Eton gains exclusive U.S. LIBERVANT commercialization rights from Aquestive
- ➤April 2027 launch anticipated, subject to final FDA approval
- ➤U.S. seizure rescue market exceeds $450 million annually
- ➤LIBERVANT tentative approval covers ages 2-5 and 12-plus
- ➤Type 9 NDA for ages 6-11 has March 29, 2027 PDUFA date
Expert Statements
Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals
“LIBERVANT marks an important expansion of our portfolio into neurology and represents a compelling opportunity to bring an orphan-designated, differentiated therapy to patients”
Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals
“The U.S. seizure rescue market exceeds $450 million annually, and we believe LIBERVANT’s innovative buccal film technology, together with Eton’s experience commercializing differentiated dosage forms, positions us well to compete in this established market.”
Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals
“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 while building another durable source of growth for our shareholders.”
Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals
“This agreement advances our strategy of acquiring and commercializing differentiated medicines, and we are excited to work with Aquestive toward an anticipated April 2027 launch,”
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
“Today marks an important new chapter for LIBERVANT and for the epilepsy community.”
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
“I am confident that Eton’s focus on specialty medicines and patient access will be essential as we work toward making LIBERVANT available to the epilepsy community.”
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
“This collaboration brings together complementary capabilities and provides a focused path to U.S. commercialization, allowing us to advance a product with the potential to address the needs of patients and caregivers seeking an alternative to nasal and rectal delivery.”
* Differentiated, portable buccal film would offer patients and caregivers an alternative to existing nasal and rectal seizure rescue treatments, a market opportunity that exceeds $450 million annually in the U.S. * Patient market research demonstrated strong preference for buccal film, with 71% of surveyed patients preferring film versus 13% for nasal spray, assuming equivalent efficacy * Anticipated commercial launch in April 2027, subject to final FDA approval, provides a potential near-term growth opportunity and new commercial platform in neurology * LIBERVANT has received Orphan Drug Designation and has issued patent protection extending into 2038, with additional patent applications pending with the U.S. Patent and Trademark Office DEER PARK, Ill. and WARREN, N.J., Oct. 14, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, and Aquestive Therapeutics, Inc. (“Aquestive”) (Nasdaq: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies, today announced that they have entered into an exclusive license agreement and a supply agreement covering the United States and its territories for LIBERVANT(®) (diazepam) buccal film, an Orphan Drug-designated, differentiated treatment for seizure clusters in patients with epilepsy. Eton anticipates commercial availability of LIBERVANT in April 2027, subject to final U.S. Food and Drug Administration (FDA) approval.
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