The Food and Drug Administration (FDA) has approved new labeling for Sorilux (calcipotriene; Mayne Pharma) Foam 0.005% for treatment of plaque psoriasis of the scalp and body in pediatric patients ≥12 years of age. Previously, the topical treatment was indicated for adult patients ≥18 years old.
Sorilux Foam contains calcipotriene, a synthetic vitamin D3 analog that has a similar receptor binding affinity as natural vitamin D3. The exact mechanism by which the treatment produces a clinical effect in psoriasis is unknown.
The approval was supported by two 8-week trials in patients 12 years of age and older, with additional data from a 15-day open-label safety and pharmacokinetics study conducted in 19 patients 12 to <17 years of age with psoriasis.
Data from 17 patients in the pharmacokinetic study showed no significant effects on indices of calcium metabolism and no quantifiable calcipotriene concentrations in patients aged 12 to <17 years. With regard to safety, adverse reactions reported in the study included application site pain, application site pruritus and pruritus.
Sorilux Foam 0.005% is supplied in 60g and 120g cans.
For more information visit soriluxfoam.com.