Aquestive Therapeutics, a renowned pharmaceutical company working towards developing and marketing various products for unmet medical demands of patients, reportedly announced that the U.S. FDA (Food and Drug Administration) sent a response letter to the company denying Aquestive’s Citizen’s Petition.
The FDA received this petition on November 1, 2019. The denial also included the supplement to Citizen’s Petition which was received by the FDA back on December 4, 2019.
Chief Executive Officer, Aquestive, Keith J. Kendall stated that this patient demographic has remained underserved for some time with little choice ahead of the rectally administered gel. The company believes that its candidate drug diazepam (Libervant™) Buccal Film would expand patient choice as the first oral dosage for this patient population, if approved.
Kendall further added that the company appreciates that FDA has stated in its response that drugs can be authorized without showing bioequivalence if they show relative bioavailability to reference drug. The FDA also stated in the response that when granting exclusivity on the basis of heavy contribution for patient care in and above already authorized products for indication, it may consider factors like duration of treatment, convenience of treatment location, reduced treatment burden, patient comfort, advances in comfort and ease of drug administration, potential for self-administration, and longer periods between doses.
In making this decision for Valtoco, the FDA, through the response, indicated that the intranasal path of administration contributes majorly to patient care over the rectal route of administration by offering a significantly enhanced ease of use.
Mr. Kendall concluded that the company looks forward to operating with the U.S. FDA during the coming months to showcase why its product candidate Libervant, as orally administered product, has one or even more of the attributes needed by the FDA so as to be considered as a major contribution for patient care in reference to the presently approved products.
Although the company is not sure about FDA’s authorization regarding Libervant, Aquestive continues its commitment to help people that are affected by seizure clusters through increasingly working on bringing vital, innovative products in the industry that would enhance patient life.