WYNZORA (betamethasone dipropionate)

AbsorptionThe pharmacokinetics of WYNZORA Cream was investigated in adult subjects in the same study as described above [see Clinical Pharmacology (12.2) ] . Their mean ± SD total body surface area involvement was 25 ± 5 % and 74% of the subjects presented with scalp involvement and with a mean ± SD scalp involvement of 52 ± 40 %. The mean ± SD weekly dose during the 8 weeks of treatment was 79 ± 30 g. Plasma concentrations of calcipotriene and betamethasone dipropionate and their major metabol...

The safety and efficacy of WYNZORA Cream were evaluated in a randomized, multicenter, 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 Gl...

The most common adverse reactions reported by more than 1% of subjects treated with WYNZORA Cream were upper respiratory infection, headache, and application site irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MC2 Therapeutics Ltd at 1-800-644-8240 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be dir...

None. None ( 4 )

Hypercalcemia and Hypercalciuria : Hypercalcemia and hypercalciuria have been observed with use of topical calcipotriene. If either occurs, discontinue until parameters of calcium metabolism normalize. ( 5.1 ) Effects on Endocrine System: Can cause reversible hypothalamicpituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over a large su...