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FDA Approves New Topical Psoriasis Therapy

The FDA has recently approved calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% (CBDP), cream for the treatment of adult patients with plaque psoriasis.1

“[This] is a novel topical treatment for plaque psoriasis [that] offers a unique combination of high efficacy, favorable safety, and excellent treatment convenience in a single product,” said lead principal investigator Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health System in Detroit, MI.

CBDP cream is a topical cream-based, fixed-dose treatment applied once per day to affected areas for up to 8 weeks. It was developed using PAD technology, which enables stability of both ingredients.

Approval was based on data from a phase 3 randomized clinical trial that compared CBDP cream (Wynzora) against an active comparator (Taclonex).2 The primary endpoint was the proportion of patients who achieved treatment success, defined as at least a 2-grade improvement from baseline on the Physician Global Assessment (PGA) to clear or almost clear at week 8. Overall, the difference in PGA treatment success was 14.6% (95% CI, 7.6%-21.6%) in favor of CBDP cream compared with the active comparator. In addition, the novel formulation of CBDP was associated with a higher proportion of patients achieving at least a 4-point improvement in peak pruritis Numeric Rating Scale at week 4 compared with the vehicle group (60.3% vs 21.4%).

Common adverse effects associated with this therapy include upper respiratory infection, headache, and application site irritation.

1. MC2 Therapeutics announces U.S. Food and Drug Administration approval of Wynzora® Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) for adults with plaque psoriasis. Press release. Business Wire; July 22, 2020. Accessed July 23, 2020.

2. MC2 Therapeutics. A clinical trial evaluating efficacy and safety of MC2-01 Cream. NCT03308799. US National Library of Medicine. Accessed July 23, 2020.


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