*See rebate card for details.
These patients achieved Physician Global Assessment (PGA) scores equating to “clear” or “almost clear” at week 81
Wynzora demonstrated a higher rate of treatment success vs the calcipotriene and betamethasone dipropionate topical suspension (Cal/BDP TS) after 8 weeks1,3
achieved treatment success with Wynzora2,3
Cal/BDP TS2,3
Vehicle2,3
83.6% of trial subjects had at least a 1-grade improvement from baseline at week 8.2
*P<0.0001 (Wynzora vs Cal/BDP TS).2
83.6% of trial subjects had at least a 1-grade improvement from baseline at week 8.2
*P<0.0001 (Wynzora vs Cal/BDP TS).2
The safety and efficacy of Wynzora cream were evaluated in a randomized, multicenter, noninferiority, vehicle- and active comparator–controlled clinical trial (NCT03308799) in adult subjects with mild to moderate plaque psoriasis. In the trial, 794 subjects were randomized to 1 of 3 treatment groups: Wynzora cream, vehicle cream, or calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064%. The majority of subjects in the trial (81.7%) had disease of moderate severity at baseline, while 18.3% of subjects had disease of mild severity. Disease severity was determined by a 5-grade Physician’s Global Assessment (PGA) scale.
The primary efficacy endpoint was the proportion of subjects with treatment success at week 8. Treatment success was defined as at least a 2-grade improvement from baseline in the PGA score and a PGA score equating to “clear” or “almost clear.” Other evaluated outcomes included a reduction in itch as defined by at least a 4-point improvement in the 11-point Peak Pruritus Numeric Rating Scale (NRS) from baseline to week 4.1
Wynzora cream was noninferior to calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% for the primary endpoint of treatment success at week 8 [difference (95% CI): 14.6% (7.6%, 21.6%)].1
In clinical trials, the majority of patients who used Wynzora experienced a statistically significant reduction in itch (P<0.0001)2
A higher percentage of subjects achieved at least a 4-point improvement from baseline on the peak pruritus NRS score at week 4 in the Wynzora group compared to the vehicle group (60.2% vs 21.4%).2
Relieving itch with Wynzora—or simply reducing its severity—is a vital component in improving patients’ quality of life
Wynzora® (calcipotriene and betamethasone dipropionate) Cream is indicated for plaque psoriasis in adults. It is not known if Wynzora Cream is safe and effective in children.
Please see Full Prescribing Information for Wynzora.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
References: 1. Wynzora® Cream [package insert]. MC2 Therapeutics; 2020. 2. Data on file. MC2 Therapeutics. 3. Præstegaard M, Vestbjerg B, Selmer J, Holm-Larsen T. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62.