Full Prescribing Information
 
Important Safety Information
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Wynzora delivered improved efficacy vs the active comparator in a head-to-head study1,2

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Before and after photos of patients who used Wynzora in a clinical trial

These patients achieved Physician Global Assessment (PGA) scores equating to “clear” or “almost clear” at week 81

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Knee
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Elbow image showing baseline Elbow image showing week 8.

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Knee image showing baseline. Knee image showing week 8.

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  • Elbow image showing baseline.

    Baseline

  • Elbow image showing week 1.

    Week 2

  • Elbow image showing week 4.

    Week 4

  • Elbow image showing week 6.

    Week 6

  • Elbow image showing week 8.

    Week 8

    • https://www.wynzora.com/wp-content/uploads/2022/02/knee-progress.png
  • Knee image showing baseline.

    Baseline

  • Knee image showing week 1.

    Week 2

  • Knee image showing week 4.

    Week 4

  • Knee image showing week 5.

    Week 6

  • Knee image showing week 8.

    Week 8

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  • Baseline

  • Week 1

  • Week 4

  • Week 6

  • Week 8

    • Some patients using Wynzora experienced visible improvements in as little as 1 week1,2

    Wynzora demonstrated a higher rate of treatment success vs the calcipotriene and betamethasone dipropionate topical suspension (Cal/BDP TS) after 8 weeks1,3

    37.4%

    achieved treatment success with Wynzora2,3

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    22.8%

    Cal/BDP TS2,3

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    3.7%

    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

    Study design

    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

    Wynzora effectively relieves itch, one of the most common and burdensome symptoms of plaque psoriasis2

    In clinical trials, the majority of patients who used Wynzora experienced a statistically significant reduction in itch (P<0.0001)2

    of patients achieved at least a 4-point improvement in itch on the Numerical Rating Scale (NRS) with Wynzora2

    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

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    Indication and Use

    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.

    Important Safety Information

    • Wynzora Cream is for topical use only.
    • Patients should not use more than 100g of Wynzora Cream per week.
    • Wynzora Cream should not be used near or in the mouth, eyes, or intravaginally.
    • Patients should avoid using Wynzora Cream on the face, groin, or armpits, or if they have atrophy at the treatment site.
    • Patients should apply Wynzora Cream to the affected areas of the skin once a day for up to 8 weeks.
    • Patients should discontinue use once the plaque psoriasis is under control.
    • Patients should not use with occlusive dressings.
    • Hypercalcemia and hypercalciuria have been observed with use of topical 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 whether Wynzora Cream may harm your unborn baby.
    • Breastfeeding women should not apply Wynzora Cream directly to the nipple and 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. 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.