Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission For Libervant™ (Diazepam) Buccal Film Following FDA Feedback
WARREN, N.J., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that the Food and Drug Administration (FDA) has provided further guidance to Aquestive regarding the information to be included in the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters. The further guidance from the FDA addresses the revised weight-based dosing regimen, modeling and simulations data that Aquestive provided to the Agency in December 2020.
“We have a clear path to resubmitting our NDA for Libervant and expect to do so around the end of the second quarter of 2021. The Agency provided additional guidance and clarity regarding information and supporting analysis that should be included in our resubmission,” said Keith Kendall, President and Chief Executive Officer of Aquestive. “We believe our focus on engaging in multiple communications with the FDA prior to resubmitting our application will ultimately result in a collaborative review process and we look forward to continuing our interactions with the FDA.”
The FDA’s written feedback provided direction on the FDA’s expectations for the information and supporting analysis relating to the population pharmacokinetic model, which the Company will be working to provide in a form acceptable to the FDA. Aquestive is aligned with the FDA’s expectations and will include the requested information in its upcoming resubmission of the NDA for Libervant. In addition, the FDA provided guidance on its expectations around the nature and format of safety data that should be included in the resubmission.
Aquestive received a Complete Response Letter (CRL) from the FDA on September 25, 2020 and subsequently completed a Type A meeting with the FDA in November of 2020. Based on the FDA’s feedback at the Type A meeting, as well as this further guidance from the Agency, Aquestive continues to believe that no further clinical studies are necessary for the resubmission of the NDA for Libervant. Once resubmitted, Aquestive anticipates a six month review process.
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.
About Aquestive Therapeutics
Aquestive Therapeutics is a pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. The Company has commercialized one internally-developed proprietary product to date, Sympazan® (clobazam) oral film, has a commercial proprietary product pipeline focused on the treatment of diseases of the central nervous system, or CNS, and other unmet needs, and is developing orally administered complex molecules to provide alternatives to invasively administered standard of care therapies. The Company also collaborates with other pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven capabilities for drug development and commercialization.
Source: Aquestive Therapeutics, Inc.
Posted: February 2021