- FDA confirms issues identified in FDA Complete Response Letter (CRL) of September 25, 2020 may be addressed by utilizing modeling and simulations for an updated dosing regimen
- FDA recommends and Aquestive agrees to a follow-up FDA meeting prior to resubmission
WARREN, N.J., Nov. 18, 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 the completion of a Type A meeting with the U.S. Food and Drug Administration (FDA) confirming a pathway for resubmission for approval of the Company’s drug candidate Libervant™ (diazepam) Buccal Film for management of seizure clusters.
In preliminary comments provided by the FDA prior to the Type A meeting and again at the Type A meeting held on November 12, 2020, the FDA confirmed that the issues identified in the CRL may be addressed by utilizing modeling and simulations based upon the information provided by Aquestive in its FDA meeting package submitted in October 2020. The FDA requested in its preliminary comments that Aquestive confirm that Libervant is linear across the potential dosage levels. Aquestive believes that this information is available based on previously conducted studies and will include this information in its upcoming resubmission of the New Drug Application (NDA) for Libervant. The FDA also recommended a follow-up meeting to review the final modeling and simulations, as well as the totality of safety information, prior to resubmission. Aquestive plans on scheduling this follow-up meeting with the FDA prior to resubmission.
Based on the FDA’s preliminary comments and the discussion with the FDA during the Type A meeting, Aquestive continues to believe that no additional clinical studies will be required for the resubmission of the NDA for Libervant. Aquestive will work to prepare the analysis requested and schedule the follow-up meeting with the FDA as soon as is practical. The Company expects to resubmit the NDA for Libervant as soon as possible after the follow-up meeting, which has yet to be scheduled.
“We are pleased with our recent interaction with the FDA,” said Keith J. Kendall, President and Chief Executive Officer of Aquestive. “The FDA has exhibited a collaborative approach to reaching a successful path for resubmission of our NDA for Libervant and we look forward to meeting with the Agency and resubmitting our NDA as quickly as possible,” concluded Mr. Kendall.