Galderma Wins FDA Approval For Vectical Ointment, A Novel Topical Therapy For Mild-To-Moderate Plaque Psoriasis

Fort Worth, TX - Galderma Laboratories, L.P. recently announced that the U.S. Food and Drug Administration (FDA) has approved Vectical (calcitriol) Ointment 3mcg/g, a unique vitamin D3 product for the treatment of mild-to-moderate plaque psoriasis in adults.

Psoriasis is a chronic skin disorder that affects 2 to 3 percent of the U.S. population. It is characterized by thick, red, scaly patches of skin and caused by an abnormally high growth rate of skin cells that form thick, dry scales (plaques). The disease is also associated with other serious conditions such as diabetes, heart disease and obesity.

Vectical Ointment is the only vitamin D3 ointment of its kind available in the United States. Vectical Ointment contains calcitriol, the naturally-occurring, active form of vitamin D3, and is one of the only vitamin D3 products shown in clinical trials to be well-tolerated even when used on sensitive skin fold areas.

"Because psoriasis is a chronic disease, topical products that are safe for extended use must fit within overall, long-term treatment regimens," said Mark Lebwohl, M.D., Department of Dermatology, Mount Sinai School of Medicine, New York. "The FDA approval of Vectical Ointment will provide doctors and patients with a new, effective tool that has been proven safe and well-tolerated throughout 52 weeks of continuous use in treating mild-to-moderate disease. A safe, effective long-term therapy is critical to improve overall outcomes for these patients."

Approval was based on two 8-week studies of more than 800 patients that compared twice-daily doses of Vectical Ointment with a vehicle treatment. In the first study, improvements in mild-to-moderate plaque psoriasis severity began to be seen at week 2, with treatment effects sustained over the 8-week treatment period. By the end of the study, 34 percent of patients achieved treatment success (GSS clear/minimal), compared with 22 percent of those treated with vehicle. Twenty-three percent of patients demonstrated success at 8 weeks and also showed a two-grade improvement in disease severity. The second study showed similar efficacy results.

SOURCE: Galderma Laboratories