Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters - Seite 2

“While we are surprised by and disappointed with the Agency’s decision, we remain committed to continuing to work with the FDA toward approval of Libervant to provide epilepsy patients with the first orally administered treatment for breakthrough and seizure clusters,” said Keith J. Kendall, President and Chief Executive Officer of Aquestive. “We look forward to quickly scheduling a meeting with the FDA to solidify Libervant’s path forward and in-turn move toward the NDA resubmission before year’s end. Epilepsy patients have been underserved for some time with little choice beyond device-based products such as rectally administered gels and nasal sprays and Libervant represents a meaningful and improved therapy for patients who can’t or won’t use the alternatives. We believe that the Company will be able to provide the necessary data to the FDA to allow for Libervant’s approval,” concluded Mr. Kendall.

Conference Call on September 25, 2020 at 6:30 p.m. ET
The Company will host a conference call today, September 25, 2020 at 6:30 p.m. to discuss the FDA’s decision. To access the conference call dial [phone] from the U.S. and [phone] internationally, followed by the conference ID: 3205078. The Company has prepared FAQs and other materials for discussion during the conference call which have been filed today under a Form 8-K filed with the United States Securities and Exchange Commission. A live webcast and these materials will be available on the Investors section of the Company’s website at https://investors.aquestive.com/events-and-presentations. The webcast and these materials will be archived for 30 days.

About Libervant
Libervant is a buccally, or inside of the cheek, administered soluble film formulation of diazepam, a benzodiazepine intended for rapid treatment of acute uncontrolled seizures in selected, refractory patients with epilepsy on stable regimens of AEDs who require intermittent use of diazepam to control bouts of increased seizure activity. Aquestive is developing Libervant as an alternative to Diastat (diazepam rectal gel), the current standard of care rescue therapy for patients with refractory epilepsy which as, a rectal gel, is invasive, inconvenient, and difficult to administer. As a result, a large portion of the patient population does not receive adequate treatment or foregoes treatment altogether. The Company believes that Libervant will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative treatment form for epileptic seizures.