Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Corporate Update (September 2020)
5 slides from Aquestive Therapeutics's corporate update, Sep 25, 2020
Slide 1: September 2020 Libervant Complete Response Letter Update
September 2020 Libervant Complete Response Letter Update
Slide 2: The Libervant development program has fully characterized the behavior of buccally-administered diazepam
The Libervant development program has fully characterized the behavior of buccally-administered diazepam Study Description Study Number Comparative bioavailability profile to Diastat in healthy volunteers Study 1899Study 1900Study 162021Study 162022Study 172018 Dose proportionality/ Linear pharmacok
Slide 3: The Libervant Complete Response Letter (CRL) is focused solely on Study 180323
The Libervant Complete Response Letter (CRL) is focused solely on Study 180323 3 While the FDA acknowledged that the overall Cmax geometric mean ratio (GMR) of Libervant versus Diastat in Study 180323 was comparable, some patients in two weight groups showed lower Cmax levels when compared to Diasta
Slide 4: Study 180323: Randomized, Open-Label Crossover Pharmacokinetic Study of Diazepam Buccal Film vs Diastat
4 Study 180323: A Randomized, Open-Label Crossover Study to Evaluate the Pharmacokinetics of Single Doses of Diazepam Buccal Film (DBF) Compared with Diastat Rectal Gel in Adult Subjects on a Concomitant Regimen of Antiepileptic Drugs (AED) for the Treatment of Epilepsy Libervant demonstrates consis
Slide 5: The linear PK profile allows the prescriber to adjust dose with predictable impact (Cmax)
The linear PK profile allows the prescriber to adjust dose with predictable impact (Cmax) 5 Figure 14.2.2-38a, Study 162013 Mean (+/-SD) Cmax vs. Dose for Diazepam
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