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Abstract Details

Inhalation as an Efficient Delivery Route of Alprazolam for the Treatment of Acute Seizures: Randomized Study of Staccato® Alprazolam Compared to Oral Alprazolam
Epilepsy/Clinical Neurophysiology (EEG)
P9 - Poster Session 9 (11:45 AM-12:45 PM)
9-009
To compare the bioavailability of alprazolam administered as Staccato® alprazolam relative to oral alprazolam.
Staccato® alprazolam is a hand-held device that can provide rapid systemic delivery of alprazolam via inhalation.
UP0104/NCT05626439 was a phase 1, open-label, randomized, single-dose, 2-way crossover trial in healthy adults (18-55 years). Pharmacokinetic endpoints were time to maximum plasma concentration (tmax), maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC) from time 0 to infinity (AUCinf), and AUC from time 0 to time of the last quantifiable concentration (AUC0-t). Safety endpoints were incidence of treatment-emergent adverse events (TEAEs)/serious TEAEs.

Twenty-one participants were randomized (mean age 38.9 years, 52.4% male). One (4.8%) participant discontinued. Median tmax of Staccato® alprazolam 2mg and oral alprazolam 2mg was 2.0min and 45.0min, respectively. Geometric mean (GeoMean) Cmax of Staccato® alprazolam 2mg was higher than oral alprazolam 2mg (44.57 vs 31.78 ng/mL; N=21/N=20). GeoMean AUCinf and AUC0-t were lower for Staccato® alprazolam 2mg (370.1 and 358.7 h*ng/mL, N=21) compared to oral alprazolam 2mg (433.9 and 420.9 h*ng/mL, N=20). As the Staccato® device delivers 90% (1.8mg) of the dose, dose-normalized geometric least-squares mean Staccato®/oral alprazolam ratios were 1.5876 for Cmax, 0.9500 for AUCinf, and 0.9488 for AUC0-t. Seven (33.3%) participants reported TEAEs while on Staccato® alprazolam 2mg of whom 5 (23.8%) reported drug-related TEAEs; 4 (19.0%) were noted to have TEAEs of decreased oxygen saturation while somnolent. None of these events were severe/serious. Additionally, 1 [4.8%] participant discontinued due to a TEAE of hypotension.
Alprazolam absorption following inhalation with the Staccato® device was fast and supports its use for rapid and early seizure termination. Dose-normalized Cmax was approximately 59% higher after Staccato® alprazolam 2mg vs oral alprazolam 2mg. No clinically relevant difference was observed on dose-normalized AUC. A single dose of Staccato® alprazolam 2mg was generally well-tolerated in healthy participants.
Authors/Disclosures
Cedric Laloyaux, PhD (UCBMedical Affairs Center of Expertise)
PRESENTER 		Dr. Laloyaux has received personal compensation for serving as an employee of UCB.
Ronald Goldwater, MD Dr. Goldwater has nothing to disclose.
Tony Daniels Tony Daniels has received personal compensation for serving as an employee of UCB. Tony Daniels has stock in UCB.
Andrea Ford Mrs. Ford has nothing to disclose.
Aliceson King Aliceson King has received personal compensation for serving as an employee of UCB Pharma. Aliceson King has stock in UCB.
Hugues Chanteux Hugues Chanteux has received personal compensation for serving as an employee of UCB. Hugues Chanteux has stock in UCB.