Quzyttir’s efficacy in treating acute urticaria was demonstrated in a phase 3 study comparing Quzyttir to IV diphenhydramine (DPH) as an active control1

African Amerian man at desk on laptop African Amerian man at desk on laptop

Phase 3 study design1

Horizontal series of three consecutive colored boxes in which the study design is stated followed by the primary efficacy endpoints and key secondary endpoints. Vertical series of three consecutive colored boxes in which the study design is stated followed by the primary efficacy endpoints and key secondary endpoints.
Select inclusion and exclusion criteria for Quzyttir phase 3 study2
Inclusion criteria:
  • Patients with a diagnosis of acute urticaria, with or without angioedema, in need of an antihistamine to alleviate symptoms
  • Subjects with a patient-rated pruritus score of ≥1
  • In patients with anaphylaxis, presence of acute urticaria after anaphylaxis symptoms had been alleviated
Exclusion criteria:
  • Any antihistamine (H1 or H2 antagonist) within the past 2 hours
  • Steroids within the past 4 hours to manage an acute allergic reaction
  • Epinephrine within the past 20 minutes
Forearm with red, speckled, angry rash representing urticaria
© James Heilman, MD. https://creativecommons.org/licenses/ by-sa/3.0/deed.en.
Urticaria, or hives (sometimes referred to as welts or wheals)3,4

Quzyttir demonstrated efficacy in reducing pruritus1

Patient-rated pruritus score change from baseline at 2 hours (primary endpoint)1
Chart representing Quzyttir's demonstrated efficacy in reducing pruritus Chart representing Quzyttir's demonstrated efficacy in reducing pruritus
  • Adjusted treatment difference (least squares estimated treatment difference [95% CI]) 0.06 (-0.28, 0.40).*†
  • Unadjusted treatment difference is 0.11.
  • Last observation carried forward; intent-to-treat population.
  • Pruritus was graded on a severity score of 0 to 3 with 0=no pruritus, 1=mild, 2=moderate, and 3=severe.
  • *Site as fixed effect.
  • †Noninferiority met statistically; lower bound of 95% CI >-0.50.
  • CI=confidence interval

Fewer return visits and shorter stays in the ED/clinic1

Two key secondary efficacy outcome measures:
The need to return to any ED or clinic after patient discharge:

In the phase 3 trial, the proportion of patients returning to any ED or clinic was lower in the Quzyttir treatment group (6%) compared to the DPH treatment group (14%). There were more than twice as many return visits with DPH than with Quzyttir1

Time spent at the treatment center (reported time from treatment administration to readiness for discharge):

In the phase 3 trial, the time spent in the treatment center was shorter in the Quzyttir treatment group (1.7 mean hours) compared to the DPH treatment group (2.1 mean hours)1

For more information or to request a rep visit, call 1-8‍66-QUZYTTIR