Pipeline Previews

Stiefel has announced that the FDA has approved a supplemental New Drug Application (sNDA) for Sorilux (calcipotriene) Foam, 0.005%. The sNDA expands the indication for Sorilux Foam to include the topical treatment of plaque psoriasis of the scalp in patients 18 years and older.

This approval was based on a multicenter, randomized, double- blind, vehicle-controlled pivotal phase 3b study of patients with moderate scalp and body psoriasis. The most common side effects of Sorilux Foam were redness and pain of the treated skin areas. The incidence of these adverse reactions was similar between the body and the scalp.

Sorilux Foam carries a number of warnings, including that it causes hypercalcemia, it is flammable, and that patients should avoid excessive exposure of the treated skin to natural or artificial sunlight (including tanning booths and sunlamps).

The FDA has posted a letter on its Web site concerning Lancôme USA's claims that Lancôme's wrinkle and skin creams "boost the activity of genes and stimulate the production of youth proteins" and "improve the condition around the stem cells and stimulate cell regeneration." Lancôme's claims are found on its own Web site.

The FDA, in its letter, warns Lancôme that such claims "indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act," referring to the Federal Food, Drug, and Cosmetic Act. The letter continues, "The marketing of these products with these claims evidencing these intended uses violates the Act," because the products were never approved as new drugs by the FDA.

Some of the Lancôme beauty products that the FDA says violate the act include: Génifique Youth Activating Concentrate, Génefique Eye Youth Activating Eye Concentrate, Génefique Cream Serum Youth Activating Cream Serum, Génifique Repair Youth Activating Night Cream, Absolue Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen, Absolue Eye Precious Cells Advanced Regenerating and Reconstructing Eye Cream, Absolue Night Precious Cells Advanced Regenerating and Reconstructing Night Cream, and Rénergie Microlift Eye R.A.R.E. Intense Repositioning Eye Lifter.

The results of a pilot single-blind trial presented at the 21st Congress of the European Academy of Dermatology and Venerology (EADV) in Prague leads researchers to conclude that methylprednisolone aceponate 0.1% (MPA; Advantan^®) provides a fast pruritus relief after first ointment application. In 5 of 10 volunteers, MPA treatment reduced pruritus (measured by a visual analog scale) by 30% in the first 5 hours posttreatment.

In the independent study, Professor Dr. Ana Giménez-Arnau, Department of Dermatology, Hospital del Mar, Barcelona, Spain, and her colleagues assessed pruritus behavior when volunteers sensitized to nickel sulfate were treated topically with Advantan^®. Pruritus was reduced by 7.1%, 15.3%, 34.3%, 26.7%, and 26.5% at 2, 4, 6, 12, and 24 hours after first use.

Advantan^® is a well-established, nonhalogenated diester corticosteroid indicated for treatment of all stages of atopic dermatitis (AD). It provides rapid and efficacious relief of signs and symptoms of AD with low incidences of systemic side effects in both adults and children. MPA belongs to the latest class of topical corticosteroids. The substance shows only limited systemic absorption and a quick inactivation of the molecule in the systemic circulation. Advantan^® is available in 5 different formulations—fatty ointment, ointment, cream, milk, and a scalp solution—and is currently marketed in more than 80 countries worldwide.

Novartis has announced new phase 2 data showing AIN457 (secukinumab) may significantly improve moderate to severe plaque psoriasis on the hands, feet, and nails when used every week for the first month of treatment, compared with placebo. Additional analysis on patients with moderate to severe plaque psoriasis also showed that AIN457 may successfully improve quality of life by week 12 in the study.

The new data come out of a double-blind, parallel group, placebo- controlled phase 2 study involving 404 patients, which met its primary end point of PASI 75 (Psoriasis Area and Severity Index) responses at week 12. The study was designed