Vectical™ Ointment (calcitriol) has been approved by the FDA for the treatment of mild-to-moderate plaque psoriasis in adults, becoming the only vitamin D3 ointment of its kind available in the United States. According to Galderma Laboratories, LP, the product contains calcitriol, the naturally-occurring, active form of vitamin D3. It was well-tolerated in clinical trials, even in sensitive skin-fold areas.

Approval was based on 2 vehicle-controlled trials of more than 800 patients. These showed improvements in mild-to-moderate plaque psoriasis severity beginning at week 2 and continuing over the entire 8-week study period. Treatment success, defined as GSS clear/minimal, was observed in 34% of Vectical-treated patients vs. 22% of vehicle-treated patients. At 8 weeks 23% of Vectical-treated patients also showed a two-grade improvement in disease severity.

"The approval of Vectical Ointment is a welcome addition to the arsenal of topical treatments for mild-to-moderate plaque psoriasis that will help patients manage their condition both safely and effectively over the long-term," said Randy Beranek, president and CEO of the National Psoriasis Foundation. "Psoriasis dramatically impacts the lives of those affected—both physically and emotionally—and we thank companies like Galderma for their ongoing commitment to bringing new therapies to this important patient community."

Galderma, which was created in 1981 as a joint venture between Nestle and L'Oreal, expects Vectical Ointment to be commercially available in the first quarter of 2009.