Warner Chilcott and LEO Pharma announced today 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 United States. Available outside the U.S. as Dovobet® or Daivobet®, Taclonex® was cleared for marketing by the U.S. Food and Drug Administration (FDA) in January. Psoriasis is a lifelong skin disease affecting more than five million adults in the United States.
"The availability of Taclonex® is significant because it makes the treatment of psoriasis easy for patients," said Dr. Mark Lebwohl, Chair, Department of Dermatology, Mount Sinai School of Medicine, New York. "It only needs to be applied once a day and is rapidly effective. In clinical studies, most patients saw improvement within the first week of use. Additionally, the two-compound ointment is more effective than either of its components alone, and also appears to be more tolerable than the components alone based on a lower percentage of total adverse events reported in clinical studies."
"At Warner Chilcott, we are continually striving to improve treatment and quality of life for people suffering from diseases of the skin," said Roger Boissonneault, CEO of Warner Chilcott. "We recognize that psoriasis can be a disabling condition that alters a person's life, both physically and emotionally, and we are pleased to provide Taclonex® as a new tool in managing its symptoms. Based on the efficacy and rapid action it has demonstrated in clinical studies, we are confident that Taclonex® will be an important new therapy for the topical treatment of psoriasis."
Taclonex® Clinical Trials
The efficacy and safety of Taclonex® have been demonstrated in seven large, multicenter clinical trials, which enrolled approximately 7,000 psoriasis patients (more than 3,000 of whom were treated with Taclonex®) amenable to topical therapy, with lesions affecting at least 10% of one or more body regions. Patients treated with Taclonex® had significantly greater and more rapid improvement in the Psoriasis Area and Severity Index (PASI) than patients treated with either calcipotriene or betamethasone dipropionate alone. In addition, Taclonex® was safe and well tolerated.
In one randomized, multicenter, double-blind trial, investigators enrolled 1,603 patients to compare the mean change in PASI from baseline to four weeks. They compared Taclonex® with calcipotriene, betamethasone dipropionate, or vehicle (placebo), 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% vs. -23.4% vs. -18.1%, p<0.001)
