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Xyzal

Clinical Pharmacology
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Clinical Pharmacology

Xyzal

The dose-ranging trial was conducted to evaluate the efficacy of XYZAL 2.5, 5, and 10 mg once daily in the evening. In this trial, each of the three doses of XYZAL demonstrated greater decrease in the reflective pruritus severity score than placebo and the difference was statistically significant for all three doses (see Table 5).

The single dose level trial evaluated the efficacy of XYZAL 5 mg once daily in the evening compared to placebo in patients with chronic idiopathic urticaria over a 4-week treatment period. XYZAL 5 mg demonstrated a greater decrease from baseline in the reflective pruritus severity score than placebo and the difference from placebo was statistically significant.

Duration of pruritus, number and size of wheals, and instantaneous pruritus severity score also showed significant improvement over placebo. The significant improvement in the instantaneous pruritus severity score over placebo confirmed end of dosing interval efficacy (see Table 5).

Table 5: Mean Reflective Pruritus Severity Score in Chronic Idiopathic Urticaria Trials

Treatment N Baseline On Treatment Adjusted Mean Difference from Placebo
Estimate 95% CI p-value
Dose-Ranging Trial–Reflective pruritus severity score
XYZAL 2.5 mg 69 2.08 1.02 0.82 (0.58, 1.06) <0.001
XYZAL 5 mg 62 2.07 0.92 0.91 (0.66, 1.16) <0.001
XYZAL 10 mg 55 2.04 0.73 1.11 (0.85, 1.37) <0.001
Placebo 60 2.25 1.84      
Chronic Idiopathic Urticaria Trial –Reflective pruritus severity score
XYZAL 5 mg 80 2.07 0.94 0.62 (0.38, 0.86) <0.001
Placebo 82 2.06 1.56      

Pediatric Patients

There are no clinical trials in pediatric patients with chronic idiopathic urticaria [see Use in Specific Populations].

Brand Name: Xyzal
Generic Name: Levocetirizine Dihydrochloride

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