Warner Chilcott, of Rockaway, NJ, and LEO Pharma A/S, of Copenhagen, Denmark, announced that Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%), a once-daily topical ointment for the treatment of psoriasis vulgaris in adults, is now available for prescription in the US. Calcipotriene is a vitamin D3 analog that helps regulate and inhibit cell growth, and betamethasone dipropionate is a potent corticosteroid that helps manage inflammation. Taclonex was cleared for marketing by the US Food and Drug Administration (FDA) in January 2006. Warner Chilcott is LEO Pharma's exclusive licensee of Taclonex in the US.

In clinical studies, the two-compound ointment is more effective than either of its components alone, and appears to be more tolerable than its components alone based on a lower percentage of total adverse events reported. Most patients saw improvement within the first week of use. In one randomized, multicenter, double-blind trial, investigators enrolled 1603 patients to compare the mean change in the Psoriasis Area and Severity Index (PASI) from baseline to 4 weeks. They compared Taclonex with calcipotriene, betamethasone dipropionate, or vehicle, all used once-daily. The study demonstrated that the mean percentage change in PASI from baseline was significantly greater for patients treated with Taclonex than for those receiving once-daily betamethasone, calcipotriene, or placebo at week 1 (-39.2% vs -33.3%, -23.4%, and -18.1%, respectively; P <.001) and week 4 (-71.3% vs -57.2%, -46.1%, and -22.7%, respectively; P <.001). To determine if Taclonex was effective in clearing lesions across all levels of psoriasis severity, data were pooled from five double-blind, placebo- and/or active-controlled studies, which randomized 2661 patients with mild-to-severe psoriasis to treatment with Taclonex, calcipotriene, betamethasone dipropionate, or vehicle. Patients were grouped according to baseline severity. All treatments were applied once-daily to lesions on the trunk or limbs over 4 weeks. The results of the analysis showed that Taclonex applied once daily had a faster onset of action and a greater reduction in mean percent PASI from baseline, regardless of disease severity (38%–41% reduction in PASI at the end of week 1, 55%–60% at the end of week 2, and 68%–72% at the end of week 4).

Developed by LEO Pharma and marketed in Europe under the brand name Daivobet®, and in Canada and the United Kingdom as Dovobet®, the product is already available in more than 60 countries outside of the US. Taclonex Ointment is indicated for the topical treatment of psoriasis vulgaris in adults 18 years of age and above for up to 4 weeks.

— A. Techman