Wynzora delivers fast improvements as early as week 1 and continual benefit through week 8 with significant reductions in pruritus1,2,5,*,†
See efficacy data
Optimized skin penetration of Cal and BDP with PADTM Technology: Cal adds to the anti-inflammatory effect of BDP to reduce the characteristic scaling of psoriasis and restore epidermal barrier function3,4,6
Explore the MOAStudy Design
The safety and efficacy of Wynzora cream were evaluated in a randomized, multicenter, noninferiority, vehicle- and active comparator–controlled clinical trial in adult patients with mild-to-moderate plaque psoriasis. In the trial, 794 patients were randomized to 1 of 3 treatment groups: Wynzora cream, vehicle cream, or Cal/BDP TS, 0.005%/0.064%. The majority of patients in the trial (81.7%) had disease of moderate severity at baseline, while 18.3% of patients had disease of mild severity. Disease severity was determined by a 5-grade PGA scale.7
The primary efficacy endpoint was the proportion of patients 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 NRS from baseline to week 4.7
BDP: betamethasone dipropionate; Cal: calcipotriene; NRS: Peak Pruritus Numerical Rating Scale; PGA: Physician Global Assessment; TS: topical suspension.
*Wynzora cream (36.0%) demonstrated a ≥1-grade PGA improvement in significantly more patients than vehicle (12.6%) at week 1 (P<0.0001).1
†Wynzora cream (37.4%) was noninferior to calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% (22.8%) for the primary endpoint of treatment success at week 8.7
‡When used as directed.
§At participating pharmacies. Limitations apply. Reduced copay for commercially insured eligible patients. Uninsured and government-insured patients are not eligible for these offers. See rebate card for details.
INDICATION: Wynzora® (calcipotriene and betamethasone dipropionate) Cream, 0.005%/0.064% is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. ADVERSE EVENTS: In the pivotal trial, the most common adverse reactions (≥1%) were: upper respiratory infection (7%), headache (2%), and application site infection (1%). WARNINGS AND PRECAUTIONS: For topical use only. Patients should not use more than 100g of Wynzora® Cream per week. Do not use near or in the mouth, eyes or intravaginally. Avoid using Wynzora® Cream on the face, groin or armpits, or if they have atrophy at the treatment site. Discontinue use once plaque psoriasis is under control or at 8 weeks. Do not use Wynzora® Cream with occlusive dressings. Hypercalcemia and hypercalciuria have been observed with topical use of calcipotriene. Wynzora® Cream can cause reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency during and after withdrawal of treatment. Wynzora® Cream may cause vision problems, including increasing the risk of cataracts and glaucoma. It is not known if Wynzora® Cream may harm your unborn baby. Breastfeeding women should not apply Wynzora® Cream directly to the nipple or areola; it is not known whether topically administered calcipotriene and betamethasone dipropionate is absorbed in human milk.
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. Pinter A, Iversen L, Praestegaard M, Stein Gold L. Fixed dose calcipotriene (CAL) and betamethasone dipropionate (BDP) cream significantly improves plaque psoriasis at week one in a pooled analysis of phase 3 data. Poster presented at: European Academy of Dermatology and Venereology Congress; September 7-10, 2022; Milan, Italy. 2. Stein Gold L, Green LJ, Dhawan S, Vestbjerg B, Praestegaard M, Selmer J. A phase 3, randomized trial demonstrating the improved efficacy and patient acceptability of fixed dose calcipotriene and betamethasone dipropionate cream. J Drugs Dermatol. 2021;20(4):420-425. doi:10.36849/JDD.2021.5653 3. Praestegaard M, Steele F, Crutchley N. Polyaphron dispersion technology, a novel topical formulation and delivery system combining drug penetration, local tolerability and convenience of application. Dermatol Ther (Heidelb). 2022;12(10):2217-2231. doi:10.1007/s13555-022-00794-y 4. Lovato P, Norsgaard H, Tokura Y, Røpke MA. Calcipotriol and betamethasone dipropionate exert additive inhibitory effects on the cytokine expression of inflammatory dendritic cell-Th17 cell axis in psoriasis. J Dermatol Sci. 2016;81(3):153-164. doi:10.1016/j.jdermsci.2015.12.009 5. Data on File. MC2 Therapeutics. 6. Satake K, Amano T, Okamoto T. Calcipotriol and betamethasone dipropionate synergistically enhances the balance between regulatory and proinflammatory T cells in a murine psoriasis model. Sci Rep. 2019;9(1):16322. doi:10.1038/s41598-019-52892-1 7. Wynzora® Cream. Package insert. MC2 Therapeutics; 2020.
