A combination of calcipotriene and betamethasone dipropionate in a foam formulation has been approved by the Food and Drug Administration for the topical treatment of plaque psoriasis in adults, according to the manufacturer.
The product will be marketed as Enstilar (calcipotriene and betamethasone dipropionate) foam, 0.005%/0.064%, by Leo Pharma.
Each gram contains 52.2 mcg calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone); it is applied to affected areas once a day for up to 4 weeks, according to the prescribing information, which states that patient should not use more than 60 g every 4 days.
The vitamin D analog-corticosteroid combination product was compared with treatment with the two individual components and/or a vehicle only, in more than 700 patients with plaque psoriasis in two studies. At baseline, about two-thirds of the patients had moderate disease, 14%-15% had mild disease, and 10% had moderately severe disease, based on a 5-point Investigator’s Global Assessment scale. The proportion of patients who were considered clear or almost clear at 4 weeks, based on IGA scale results, was the efficacy endpoint defining treatment success. Among patients with mild disease at baseline, treatment was considered successful if they were considered clear at 4 weeks.
In one study of 302 patients, 45% treated with the combination product had achieved treatment success at week 4 vs. 30.7% of those treated with betamethasone and 14.9% treated with calcipotriene, according to the prescribing information. In the second study, 323 patients were treated with the combination product and 103 received the vehicle. At 4 weeks, 53.3% of those treated with the foam met the efficacy endpoint vs. 4.8% of those in the vehicle group.
Application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and psoriasis exacerbations were among the adverse reactions reported in fewer than 1% of those treated with the combination product. The warnings and precautions section of the prescribing information includes a statement noting that the product contains propellants that are flammable, and that patients should be advised to “avoid fire, flame, or smoking during and immediately after using this product.”
This approval is for an adult population. As a postmarketing commitment, the FDA is requiring that the company conduct a study in pediatric patients with plaque psoriasis, according to the agency’s approval letter, dated Oct. 16. That study is described as an open-label study to assess the effect of the product on calcium metabolism in pediatric patients aged 12-16 years, with plaque psoriasis of the scalp and body. In a subgroup of these children, pharmacokinetics and hypothalamic-pituitary axis suppression also will be assessed, the letter says.
Serious adverse events associated with this product should be reported to the FDA’s MedWatch program at 800-332-1088, or http://www.fda.gov/Safety/MedWatch/default.htm.