Abstract Details

Title Pulmonary Safety of Staccato® Alprazolam in Healthy Participants and Participants with Mild Asthma: Phase 1, Randomized, Double-blind, Placebo-controlled Trial

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P9 - Poster Session 9 (8:00 AM-9:00 AM)

Poster/Presentation
Number 1-009

Objective Evaluate pulmonary safety of repeat dosing of Staccato^® alprazolam (STAP) in healthy participants and those with mild asthma.

Background STAP is a hand-held device providing rapid systemic delivery of alprazolam via inhalation.

Design/Methods UP0099 (NCT04802746) was a randomized, double-blind clinical study evaluating 2 doses of STAP administered 72h apart (Day1 and Day4) in adults (18-55yrs). Part-A evaluated STAP 1mg/2mg vs placebo in healthy participants. Part-B evaluated STAP 2mg vs placebo in participants with mild asthma. Primary endpoints: spirometric assessments of forced expiratory volume in 1sec (FEV₁); repeated measures ANCOVA; respiratory treatment-emergent adverse events (respiratory-TEAEs).

Results Part-A enrolled 30 participants (mean age 30.7yrs; 56.7% female); 2/30 discontinued. Day1: mean FEV₁ showed greater decrease from baseline vs placebo at 5min postdose for STAP 1mg (-0.076L vs -0.007L) and 2mg (-0.099L vs -0.007L) and at 20min for 2mg (-0.080L vs -0.029L). Differences were statistically significant but not clinically relevant. Day4: changes from baseline were less marked and similar across groups. Respiratory-TEAEs (all cough) were reported by 8/29, 12/29, and 0/28 participants on STAP 1mg, 2mg, and placebo, respectively, on Day1, and by 8/29, 9/28 and 0/28 on Day4. Part-B enrolled 48 participants (mean age 33.3yrs; 60.4% female); 1/48 discontinued. Day1: mean FEV₁ showed greater decrease from baseline for STAP 2mg vs placebo at 5min (-0.245L vs -0.045L) and 20min (-0.178L vs -0.013L) postdose. Differences were statistically significant but not clinically relevant. Day4: changes from baseline in FEV₁ were less marked than on Day1. Respiratory-TEAEs (most commonly cough) were reported by 16/23 participants on STAP 2mg on Day1, and 15/22 participants on Day4 (placebo: no respiratory-TEAEs).

Conclusions

STAP (1mg/2mg) administered 72h apart was well tolerated in healthy participants and those with mild asthma. Minor decreases in FEV₁ from baseline were observed with STAP vs placebo; these were not clinically relevant. Cough was the most common respiratory-TEAE.

Authors/Disclosures
Jeanne A. Vander Zanden, PharmD, BCPP (UCB) PRESENTER	Dr. Vander Zanden has nothing to disclose.
S David Miller	No disclosure on file
Craig LaForce	No disclosure on file
Laura Barlow	No disclosure on file
Aliceson King	Aliceson King has received personal compensation for serving as an employee of UCB Pharma. Aliceson King has stock in UCB.
Maria Burian (UCB Biopharma)	No disclosure on file
Hugues Chanteux	Hugues Chanteux has received personal compensation for serving as an employee of UCB. Hugues Chanteux has stock in UCB.

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