SORILUX Rx

Indication(s):

Topical treatment of plaque psoriasis in patients ≥18 years of age.

Pharmacology:

Calcipotriene is a synthetic vitamin D₃ analog that has a similar receptor binding affinity as natural vitamin D₃. However, the exact mechanism of action contributing to the clinical efficacy in the treatment of psoriasis is unknown.

Clinical Trials:

In two multi-center, randomized, double-blind, vehicle-controlled clinical studies a total of 659 subjects with psoriasis were randomized 2:1 to SORILUX Foam or vehicle; subjects applied the assigned medication twice daily for 8 weeks. Baseline disease severity was graded using a 5-point Investigator Static Global Assessment scale (ISGA), defined as (Clear = grade 0: no evidence of scaling, erythema, or plaque thickness; Almost clear = grade 1: occasional fine scale, faint erythema, and barely perceptible plaque thickness; Mild = grade 2: fine scale with light coloration and mild plaque elevation; Moderate = grade 3: coarse scale with moderate red coloration and moderate plaque thickness; Severe = grade 4: thick tenacious scale with deep coloration and severe plaque thickness) on which subjects scored either “mild” or “moderate”.

Efficacy evaluation was carried out at Week 8 with treatment success being defined as a score of “clear” (grade 0) or “almost clear” (grade 1) and at least 2 grade improvement from the baseline score. Approximately 30% of enrolled subjects were graded as “mild” on the ISGA scale. The study population ranged in age from 12–89 years with 10 subjects <18 years of age at baseline. The subjects were 54% male and 88% Caucasian. In Study 1, 14% of subjects treated with Sorilux foam were classified as successful at Week 8 compared to 7% of subjects treated with vehicle only. In this study subjects graded as “mild” at baseline showed a greater response to vehicle than to Sorilux foam. In Study 2, 27% of subjects treated with Sorilux foam experienced treatment success at Week 8 compared to 16% using vehicle alone.

Legal Classification:

Rx

Adults:

≥18yrs: Apply a thin layer twice daily to affected areas and gently rub in completely.

Children:

<18yrs: not established.

Contraindication(s):

Hypercalcemia.

Warnings/Precautions:

Not for oral, ophthalmic, or intravaginal use. Discontinue if hypercalcemia occurs (until normocalcemia returns). Avoid eyes, excessive sunlight, phototherapy. Flammable. Pregnancy (Cat.C). Nursing mothers.

Adverse Reaction(s)

Erythema.

How Supplied:

Foam—60g, 120g

LAST UPDATED:

10/31/2012