FDA Approves Calcitriol Ointment for Psoriasis

Laurie Barclay, MD

February 05, 2009

February 5, 2009 — The US Food and Drug Administration (FDA) recently approved calcitriol ointment 3 μg/g (Vectical, Galderma Laboratories, LP), a first-of-its-kind, topical ointment, using a naturally occurring active form of vitamin D3 to treat psoriasis.

For treatment of mild-to-moderate psoriasis plaque in adults aged 18 years and older, calcitriol ointment has been proven safe, even for use in sensitive skin areas, and well-tolerated for continuous use up to 1 year. Calcitriol ointment, which is believed to help regulate excessive skin cell production by binding to the vitamin D receptors on keratinocytes (skin cells), is the only vitamin D3 ointment of its kind available in the United States.

"Because psoriasis is a chronic disease, topical products that are safe for extended use must fit within overall, long-term treatment regimens," Mark Lebwohl, MD, from Mount Sinai School of Medicine in New York City, said in a news release. "The [ointment]...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."

FDA approval was based on findings from two 8-week studies of more than 800 patients comparing twice-daily doses of calcitriol ointment with vehicle. Improvements in mild-to-moderate plaque psoriasis severity in the first study were first apparent at week 2, and these benefits were sustained during the 8-week treatment period.

Treatment success, defined as a global severity score of clear/minimal, was achieved by study end in 34% of patients treated with calcitriol ointment vs 22% of those treated with vehicle. At 8 weeks, 23% of patients achieved treatment success and also had a 2-grade improvement in disease severity. Efficacy results were similar in the second study.

The calcitriol ointment and vehicle groups had similar treatment-related adverse events. The most common adverse events (reported in more than 3%) were laboratory test abnormality, urine abnormality, psoriasis, hypercalciuria, pruritus, and skin discomfort.

A long-term, 52-week safety study showed that adverse events were similar to those reported in the 8-week studies. Although the 8-week studies showed some transient increases in plasma calcium levels, calcitriol ointment was not associated with any significant clinical effects on calcium homeostasis when used continuously during the 52-week study.

Psoriasis, a chronic skin disorder affecting 2% to 3% of the US population (about 7.5 million people) is characterized by thick, red, dry, scaly patches of skin and is caused by an abnormally high growth rate of skin cells that form plaques. Physical symptoms include inflammation, infection, soreness, and burning.

Patients with psoriasis may also have diabetes, heart disease, and obesity. Other available prescription options for psoriasis include corticosteroids, which are not typically used long term.

"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 chief executive officer of the National Psoriasis Foundation.

The maximum recommended dose is not more than 200 g per week. Calcitriol ointment should be used with caution in patients who have known or suspected disturbances in calcium homeostasis, who take calcium or vitamin D supplements, or who use thiazide diuretics or other medications known to increase serum calcium levels. If abnormalities of calcium metabolism occur during treatment, calcitriol ointment should be withheld until these normalize.

Patients should avoid excessive exposure to natural or artificial sunlight after applying calcitriol ointment, discontinue use if severe irritation occurs, and avoid contact with eyes, lips, and face. Calcitriol ointment has not been studied in pregnant or nursing women.

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