Aquestive Gets FDA Tentative Approval For Libervant In Seizure Clusters Management

The U.S. Food & Drug Administration (FDA) has granted tentative approval for Aquestive Therapeutics’ AQST lead asset Libervant (diazepam) Buccal Film 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 12 years of age and older.

By means of ‘Tentative approval’, the regulatory agency has concluded that Libervant has met all required quality, safety, and efficacy standards for approval but, due to an existing FDA regulatory grant of orphan drug market exclusivity for Valtoco, a diazepam nasal spray product. Libervant is not yet eligible for marketing in the United States.

Daniel Barber, Chief Executive Officer, commented: "The tentative approval of Libervant is a significant achievement that brings us one step closer to bringing this important medicine to patients who are unable or choose not to use the current standards of care. Libervant has the potential to offer these patients a treatment option that is simple, portable, and precise. A significant unmet need exists for additional alternate delivery options given the ongoing shortage of diazepam rectal gel, which continues to represent a substantial portion of the current diazepam rescue market.”

The FDA's decision concluded that the data Aquestive submitted was not sufficient to overturn the its previous conclusion regarding the lack of food effect for Valtoco.

Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older.

Price Action : Aquestive shares are trading around 7 percent down at $1.41 on Wednesday during pre-market session.