Hugues Chanteaux, PhD, Quantitative Clinical Pharmacology Lead at UCB, discusses results from a study evaluating two different routes of alprazolam administration, inhaled (“Staccato”) versus oral administration in patients with acute seizures.

 


 

NCT05626439 was a phase 1, single center, open-label, randomized, single-dose, 2-way crossover study evaluating Staccato alprazolam 2 mg versus oral alprazolam 2 mg in healthy adult participants. Staccato alprazolam uses a handheld device that can provide rapid systemic delivery of the treatment via inhalation. Alprazolam is a benzodiazepine that binds to the GABA-A receptor that mediates calming or inhibitory effects on the nervous system. 

A total of 21 participants were randomized in the study. The Staccato device enabled rapid systemic delivery of alprazolam, achieving clinically relevant plasma concentrations within 2 minutes post-dose. This is compared to 45 minutes for oral administration. The peak concentration of Staccato alprazolam 2 mg was higher than oral alprazolam 2 mg, though overall drug exposure was lower. Distribution and elimination were similar between both methods, with inhalation showing significantly faster absorption. Urinary excretion of unchanged alprazolam was minimal for both forms. These findings suggest that the Staccato device is an efficient delivery method for acute seizure treatment.

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