Aquestive Therapeutics, Inc. (NASDAQ: AQST) today reported that the U.S. Food and Drug Administration (FDA) issued a response letter (Response) dated January 10, 2020 denying Aquestive's Citizen's Petition received by the FDA on November 1, 2019, including the supplement to the Citizen's Petition received by the FDA on December 4, 2019 (Docket No. FDA-2019-P-5121) (Petition). The Petition requested, among other things, that the FDA stay approval of a New Drug Application for Valtoco® (diazepam nasal spray) submitted by Neurelis, Inc. until additional clinical studies were conducted. In the Response, the FDA indicated that it had approved Neurelis's NDA for Valtoco on January 10, 2020. Valtoco has received orphan drug exclusivity from the FDA's Center for Drug Evaluation and Research commencing as of January 10, 2020 for the labeled indication of 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 six years of age and older.
"This patient population has been underserved for some time with little choice beyond the rectally administered gel and choice is important. We believe that our candidate drug Libervant™ (diazepam) Buccal Film will, if approved by the FDA, further expand patient choice as the first orally administered dosage form for this patient population," said Keith J. Kendall, Chief Executive Officer of Aquestive.
"We appreciate that the FDA has confirmed in the Response its guidance that 505(b)(2) drugs can be approved without proving bioequivalence if they demonstrate "relative bioavailability" to the reference drug. The FDA stated in the Response, when granting exclusivity based upon "major contribution to patient care" over and above already approved products for the indication, it may consider such factors as convenience of treatment location, duration of treatment, patient comfort, reduced treatment burden, advances in ease and comfort of drug administration, longer periods between doses, and potential for self-administration. In making this determination for Valtoco, the FDA indicated in the Response that the intranasal route of administration provides a major contribution to patient care over the rectal route of administration by providing a significantly improved ease of use."
"We look forward to working with the FDA in the coming months to demonstrate why we believe that our product candidate Libervant, as an orally delivered product for this indication, has one or more of the attributes required by the FDA to be considered a major contribution to patient care relative to the currently approved products," concluded Mr. Kendall.
Although we cannot be assured of FDA approval of Libervant, Aquestive remains committed to helping people affected by seizure clusters by looking to bring important innovative products to the market that will improve the lives of patients.
We provided preliminary 2020 revenue guidance in our press release dated January 10, 2020. As a reminder, we did not include any Libervant revenues in that guidance.