Aquestive Therapeutics Inc. (NASDAQ: AQST) shares lost nearly a third on Monday after the firm received an update from the U.S. Food and Drug Administration (FDA). The long and short of this is that Aquestive’s seizure treatment may get butted out by another FDA approval.
Essentially, the FDA issued a response letter denying Aquestive’s citizen’s petition that the agency had received in early December. The citizen’s petition requested, among other things, that the FDA stay approval of a New Drug Application for Valtoco submitted by Neurelis 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 received orphan drug exclusivity from the FDA’s Center for Drug Evaluation and Research commencing as of January 10 for the indication of acute treatment of intermittent stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy six years of age and older.
The FDA stated in the response, when granting exclusivity based on “major contribution to patient care” over and above already approved products for the indication, that the agency believes 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.
Keith J. Kendall, CEO of Aquestive, commented:
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.
For some quick background: Aquestive’s Libervant is a buccally, or inside of the cheek, treatment of acute uncontrolled seizures in refractory patients with epilepsy on stable regimens of AEDs who require intermittent use of diazepam 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.
Shares of Aquestive were last seen down 31% at $4.54, in a 52-week range of $2.95 to $10.00. The consensus price target is $18.17.