The single dose crossover study is designed to compare Libervant and its reference listed drug, Diastat® Rectal Gel, in the same patient population, and provide the final set of data validating the Libervant dosing model. Aquestive has exceeded its target enrollment in the study and dosed more than 24 adult patients. Based on the approved study protocol, each patient is intended to receive a single dose each of Libervant and Diastat. The administration of each medication is being randomized over two visits, with a minimum 28-day wash-out period required between the first and second dosing. The primary endpoints are measures of blood plasma levels - including Cmax, Tmax, and AUC measurements - monitored for 10 days following each dosing. Additionally, the study will track product safety and tolerability. Analysis of this data will be done in the third quarter 2019 and be used to complete the NDA filing in the fourth quarter 2019.
"We are pleased that the crossover study recruitment and expected date of study completion are both tracking ahead of schedule, and we are moving ahead with the NDA filing," said
Among the 3.4 million epilepsy patients in the U.S., an estimated 1.2 million experience refractory or breakthrough seizures. These patients require a rescue strategy they can employ at the onset of increased seizure activity to prevent high cost emergency situations and poor outcomes. The current standard for treatment is Diastat, a rectal gel formulation of diazepam, which is underused by the patient population. Limited alternatives have left most patients without an effective and preferred treatment option.
"Libervant can provide the right medicine, at the right dose, in a form many patients would prefer to use," continued Mr. Kendall. "We believe Libervant will be an important innovation that can provide a material contribution to, and improvement in patient care, increasing the options and solutions available for patients, prescribers and caregivers seeking a reliable and fast-acting rescue treatment for breakthrough seizures or seizure clusters."
Libervant is a novel formulation of diazepam administered as a thin film strip, placed inside the cheek. Libervant leverages Aquestive's proprietary PharmFilm® technology. If approved, Libervant can be carried by patients and administered without invasiveness to help lessen subsequent seizures.
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