Aquestive Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update

By Globe Newswire7 days ago

  • On track to refile Libervant™ (diazepam) Buccal Film New Drug Application (NDA) by end of second quarter 2021
  • Initiated first-in-human Phase 1 pharmacokinetic (PK) study for AQST-109 epinephrinesublingual film candidate
  • Sympazan® (clobazam) continues to meet key performance metrics and gain market share
  • Hosts conference call at 8:00 a.m. ET on May 5, 2021

WARREN, N.J., May 04, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients' unmet needs and solve therapeutic problems, today reported financial results for the first quarter ended March 31, 2021 and provided an update on recent developments in its business.

We arefocused on continuing to make progress this year in advancing our proprietary products. In response to feedback from the FDA, we are developing additional analyses of the existing clinical data in the NDA for Libervant and expect to refile by the end of the second quarter of 2021. We recently initiated the first-in-human Phase 1 PK study with our second generation epinephrine candidate AQST-109 and anticipate reporting top-line data in the second half of the year, said Keith Kendall, President and Chief Executive Officer of Aquestive.



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 in selected, refractory patients with epilepsy on stable regimens of AEDs who require intermittent use of diazepam to control bouts of increased seizure activity. The Company is developing Libervant as an alternative to more invasive, inconvenient, and difficult to administer device driven products, including a rectal gel, for patients with refractory epilepsy. As a result of these issues, a large portion of the patient population does not receive adequate treatment or foregoes treatment altogether. The Company believes that Libervant, if approved by the FDA for U.S. market access, will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative treatment form.

The Company previously received a Complete Response Letter (CRL) from the FDA in September 2020. Since September, Aquestive has engaged with the FDA and developed a plan to address the deficiencies noted in the CRL. Aquestive continues to believe that no additional clinical studies will be required to resubmit the NDA. The Company anticipates a six month review process and PDUFA action dateby the end of 2021.

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