Aquestive Therapeutics Inc. (NASDAQ: AQST) shares jumped early on Monday after the firm announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its therapeutic candidate Libervant (diazepam) buccal film.
Libervant is a buccally, or inside of the cheek, administered soluble film formulation of diazepam, a benzodiazepine intended for rapid treatment of acute uncontrolled seizures to control bouts of increased seizure activity.
Aquestive is developing Libervant as an alternative to Diastat (diazepam rectal gel), the current standard of care rescue therapy for patients with refractory epilepsy, which as a rectal gel, is invasive, inconvenient and difficult to administer.
As a result, a large portion of the patient population does not receive adequate treatment or forgoes treatment altogether. Ultimately, it’s expected that Libervant will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a noninvasive and innovative treatment form for epileptic seizures.
Keith J. Kendall, CEO of Aquestive Therapeutics, commented:
We are very pleased to have completed our NDA filing for Libervant as we had committed. We look forward to sharing the results from the single dose crossover study at the upcoming American Epilepsy Society 2019 Annual Meeting. We believe these results confirm our dosing algorithm and satisfy the final clinical requirement requested by the FDA. We believe that Libervant has the potential to be the first oral therapy approved by the FDA for the management of seizure clusters in the population of 1.2 million refractory epilepsy patients and the first diazepam based treatment usable by and delivering a consistent predictable dose to virtually all patients to whom it will be prescribed.
Shares of Aquestive Therapeutics traded up about 8% to $8.42 early Monday, in a 52-week range of $2.95 to $9.32. The consensus price target is $18.50.