Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that, regarding the review of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the treatment of breakthrough seizures and seizure clusters, the U.S. Food & Drug Administration (FDA) sent the following notice to the Company;
“Please refer to your NDA 212641 Libervant resubmission dated June 23, 2021.
The purpose of this e-mail is to notify you that the Agency is still considering the regulatory issues related to the approvability of Libervant, and will not be ready to take an action by December 23, 2021. No additional information is needed from you at this time. We are currently unable to provide an estimate of the timing of an expected action; however, we will provide any updates we can as they are available.”
“We are surprised to receive this notification from the FDA. We accepted all of the Agency’s label edits for Libervant last week and, as the Agency stated in its notice today, there is no additional information needed from the Company at this time. Following the labeling discussions, we believe the package we submitted satisfies all of CDER’s requests,” said Keith Kendall, Chief Executive Officer of Aquestive. “We are currently reaching out to the FDA to seek further clarity. We remain fully committed to working closely with the FDA for the duration of its review of our NDA. We continue to believe that Libervant provides a major contribution to patient care and has the potential to transform the lives of refractory epilepsy patients seeking a non-invasive and innovative product for the management of seizure clusters.”
In July 2021, the FDA accepted the NDA for Libervant and assigned a Prescription Drug User Fee Act (“PDUFA”) target goal date of December 23, 2021.
The Company continues to advance AQST-109 as it began the EPIPHAST study, the results of which are expected to be available in the first half of 2022.
About Libervant
Libervant™ is a buccally, or inside of the cheek, administered soluble film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. The Company believes that Libervant will enable a larger share of patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative treatment form for epileptic seizures. Aquestive developed Libervant as an alternative to more invasive, inconvenient, and difficult to administer device driven products, including a rectal gel and nasal spray, for patients with refractory epilepsy. A large portion of the patient population still does not access either one of these existing products and remains underserved with regard to having an important medication where they need it, when they need it and in a form they prefer. Libervant was granted Orphan Drug Designation by the FDA in November 2016.
About AQST-109
AQST-109 is a polymer matrix-based film that can be applied sublingually (under the tongue) for the rapid delivery of epinephrine. The product is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for AQST-109 is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Company has begun recruiting subjects for its EPIPHAST adaptive design study. Results of the study will be available in the first half of 2022.
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