Aquestive Hands U.S. Rights to LIBERVANT to Eton as It Prepares for an April 2027 Launch

Aquestive Therapeutics (NASDAQ: AQST) has signed an exclusive U.S. licensing and supply agreement with Eton Pharmaceuticals (NASDAQ: ETON) for LIBERVANT® (diazepam) buccal film. LIBERVANT is Aquestive’s rescue treatment for seizure clusters in people with epilepsy. Eton will sell the product in the U.S., and Aquestive will make and supply it. The deal puts a commercial partner behind one of Aquestive’s late-stage film products a few months before a key regulatory window opens. As a result, Eton expects LIBERVANT to be available in April 2027, subject to final FDA approval.

Key Points

• Aquestive gave Eton exclusive U.S. commercialization rights to LIBERVANT and will remain its exclusive manufacturer and supplier.
• Aquestive can earn upfront, milestone and royalty payments tied to FDA approvals and net sales. The financial terms were not disclosed.
• LIBERVANT holds tentative FDA approval. Full approval for patients 12 and older is expected after a competing product’s orphan exclusivity ends on January 10, 2027.
• A pending application would add children aged 6 to 11. Its FDA target action date is March 29, 2027.
• The U.S. seizure-rescue market is worth more than $450 million a year, and LIBERVANT’s patents run into 2038.

A Device-Free Rescue Option for Seizure Clusters

LIBERVANT is a thin film that patients place inside the cheek, where it dissolves. It needs no device. It treats seizure clusters, also called acute repetitive seizures, which are episodes that differ from a patient’s usual seizure pattern. The film is for occasional rescue use, not daily maintenance. It holds FDA Orphan Drug Designation, which it received in November 2016.

The product currently has tentative FDA approval for patients aged 2 to 5 and 12 and older. Patients 12 and older should become eligible for full approval once VALTOCO’s orphan exclusivity expires on January 10, 2027. In addition, a supplemental application to add ages 6 to 11 is under FDA review, with a target date of March 29, 2027. If approved, the label would cover patients aged 6 and older.

Patient feedback also supports the format. In a third-party survey of 101 patients, 76% said they worried about not having their rescue medication within reach away from home. Only 34% said they always carry it outside the house. Furthermore, 71% said they would prefer a film over a nasal spray if the two worked equally well, while 13% preferred the spray. These are stated preferences, not clinical results.

Why the Deal Matters for Aquestive (AQST)

The agreement fits Aquestive’s model as both a drug developer and a contract manufacturer built on its PharmFilm® oral-film technology. Aquestive already makes four commercial products that partners sell. LIBERVANT now follows that path, so Aquestive keeps manufacturing revenue and potential royalties without building its own neurology sales force.

Aquestive CEO Daniel Barber said Eton’s focus on specialty markets and patient access will be key to reaching the epilepsy community. He described the partnership as a focused path to U.S. commercialization.

For Eton, LIBERVANT marks a move into neurology. Eton already sells eleven rare-disease products and plans to build a dedicated neurology team on its existing commercial infrastructure. Eton CEO Sean Brynjelsen called the deal a meaningful expansion. He said Eton’s experience selling film products positions it well in an established market.

A Busy Regulatory Calendar Ahead

The LIBERVANT deal lands while Aquestive is also pursuing approval for Anaphylm™, its needle-free epinephrine film for severe allergic reactions. As PRISM MarketView reported in September, Aquestive resubmitted the Anaphylm New Drug Application after completing studies the FDA requested in a January 2026 Complete Response Letter. Investors now have several catalysts to watch: the January 2027 exclusivity expiry, the March 2027 pediatric target date, an April 2027 commercial launch and the Anaphylm review.

Positioned Within the PRISM Biotech Index

Aquestive is a component of the PRISM Biotech Index, which tracks small- and micro-cap companies driving healthcare innovation. The LIBERVANT agreement shows a common strategy among index members: license a late-stage asset to a commercial partner and keep the economic upside.

As both Aquestive and Eton note in their forward-looking statements, the outcome still depends on final FDA approval, the timing of competitors’ exclusivity, supply and reimbursement.