Benzinga | Sep 28, 2020 07:30AM EDT

Aquestive Therapeutics Late Friday Received A Complete Response Letter From FDA For Libervant Buccal Film Indicating The Application Cannot Be Approved In Its Current Form; Letter 'cites exposure levels (Cmax) in certain weight groups'

* Complete Response Letter cites exposure levels (Cmax) in certain weight groups

* No additional clinical studies anticipated by Aquestive

* No Clinical Safety issues or Non-Clinical Chemistry, Manufacturing and Controls (CMC) issues identified

* Conference call and webcast today at 6:30 p.m. ET

WARREN, N.J., Sept. 25, 2020 (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, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant(tm) (diazepam) Buccal Film for management of seizure clusters. The FDA issues a CRL to indicate that the review cycle for an application is complete but the application cannot be approved in its current form.

In the CRL, the FDA cited that, in a study submitted by the Company with the NDA, certain weight groups showed a lower drug exposure level than desired. The Company intends to provide to the FDA additional information on PK modeling to demonstrate that dose adjustments will obtain the desired exposure levels. There were no other safety, clinical pharmacology/biopharmaceutics or CMC issues identified in the CRL. The FDA did cite a small number of protocol deviations in blood draws in one of the studies in the NDA. The Company believes, based on discussions with the FDA, that the Company will not need to conduct any further clinical studies in order to cure the items cited in the CRL, and will confirm that view in its upcoming follow-up meeting with the FDA.

Based on interactions with the Agency, the Company believes that this CRL will not be a barrier to ultimate approval, as the CRL was limited to providing additional information on PK modeling for an adjusted dosing regimen for a limited subset of patient weight categories. The Company plans to request a Type A meeting with the FDA in the coming weeks and to resubmit the NDA prior to the end of 2020 with the adjusted dosage regimen for the identified weight groups at issue. A submission before the end of the year should result in a PDUFA Action Date in the 1st half of 2021. The Agency did not include any indication regarding approval of U.S. market access for Libervant at this time.

"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.