The Food and Drug Administration (FDA) has approved Quzyttir (cetirizine hydrochloride injection; JDP Therapeutics) for the treatment of acute urticaria in adults and children 6 months of age and older.
Quzyttir, a histamine-1 (H1) receptor antagonist, is a single-use injectable product for intravenous administration. The approval was based on data from a phase 3 active-controlled, double-blind, parallel group study that included 262 patients 18 years of age and older with acute urticaria. Patients were randomized to receive Quzyttir 10mg or diphenhydramine 50mg injection; the primary efficacy end point was the change from baseline in patient-rated pruritus score assessed 2 hours following treatment for the intent-to-treat population.
Results showed that the effectiveness of Quzyttir was found to be noninferior to diphenhydramine. Change from baseline in patient-rated pruritus score (graded on a scale of 0 to 3, where 0 is no pruritus and 3 is severe) was -1.61 for Quzyttir vs -1.50 for diphenhydramine (adjusted difference: 0.06 [95% CI, -0.28, 0.4]).
As for secondary outcomes, 6% of Quzyttir-treated patients returned to the emergency department or clinic compared with 14% of those treated with diphenhydramine. Moreover, the time spent in the treatment center (time from treatment administration to readiness for discharge) was shorter in the Quzyttir group (1.7 hours) compared with the diphenhydramine group (2.1 hours).
The efficacy of Quzyttir for the treatment of urticaria in pediatric patients aged 6 months and older is based on extrapolation of the efficacy in adults with acute urticaria and supported by pharmacokinetic data with oral cetirizine hydrochloride. The treatment is not recommended in children less than 6 years of age with impaired renal or hepatic function.
With regard to safety, treatment-emergent adverse reactions included dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis.
Quzyttir will be supplied in single-use vials containing 1mL of drug solution with 10mg cetirizine hydrochloride (equivalent to 8.42mg of cetirizine).
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