Psoriasis Ointment Gets FDA Approval

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Updated: 3/29/2013 10:58 pm

Feb. 3, 2009 -- A new psoriasis treatment, Vectical, is the first FDA-approved ointment containing calcitriol, the active form of vitamin D3.

The FDA has approved Vectical for use by adults 18 and older with mild-to-moderate psoriasis. Studies in children are under way.

There's still no cure for psoriasis. But clinical trials show that Vertical is safe during one year of continuous use.

"Because psoriasis is a chronic disease, topical products that are safe for extended use must fit within overall, long-term treatment regimens," says Mount Sinai School of Medicine dermatologist Mark Lebwohl, MD, in a news release. "A safe, effective, long-term therapy is critical to improve overall outcomes for these patients."

Side effects of Vectical include changes in the way the body uses calcium. People with known or suspected disturbances in calcium metabolism are warned to use Vectical with caution. That warning also goes for people taking drugs, such as thiazide diuretics, that affect calcium levels.

Caution is also advised for patients taking calcium or vitamin D supplements. And while using Vectical, patients are warned against "excessive exposure" to natural or artificial sunlight. The product has not yet been tested in pregnant or nursing women.

How well does Vertical work?

In two eight-week studies of more than 800 psoriasis patients with mild-to-moderate psoriasis, about a third of patients had either psoriasis plaque clearing or minimal psoriasis symptoms. Similar relief was seen by only about a fifth of patients treated with the ointment base lacking the active calcitriol ingredient.

While Vectical is the only topical calcitriol product in the U.S., two other products, Dovonex and Taclonex, contain a vitamin D derivative called calcipotriene. Taclonex combines calcipotriene with a steroid. Another psoriasis treatment, Tazorac, contains a vitamin A derivative.

One possible advantage of Vectical is that it can be applied to sensitive skin-fold areas. Other vitamin D products have been linked to irritation in these areas.

Most doctors use corticosteroid treatments to get psoriasis flare-ups under control. But these drugs typically are not indicated for long-term use.

Vectical is made by Galderma Laboratories, a joint venture of Nestle and L'Oreal.

 

 

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