The U.S. Food and Drug Administration (FDA) approved Vectical™ (calcitriol) Ointment 3mcg/g, a vitamin D3 product for the treatment of mild-to-moderate plaque psoriasis in adults. Vectical Ointment is a product of Galderma Laboratories, LP, Ft. Worth, Tex and 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, MD, 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% of patients achieved treatment success (GSS clear/minimal), compared with 22% 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.
Vectical™ Ointment will be available by prescription in pharmacies in the first quarter of 2009.
[Source: original press release]