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March 18, 2004
Results from two phase III studies of oral tazarotene, an oral version of the retinoid Tazorac, found that patients experienced peak clearing at four weeks after the treatment period, with no significant side effects.
A total of 263 adult patients with plaque psoriasis covering at least 10 percent of their body surface took 4.5 milligrams (mg) once daily for up to 52 weeks.
More than half of the patients achieved moderate to complete clearing by week 12. The majority of patients maintained improvement throughout the treatment period and for at least 12 weeks post treatment.
The most common adverse events were mild, and included dry skin, joint pain, muscle ache, infection, back pain, headache and itch.
Oral tazarotene did not accumulate in the body and cleared rapidly when treatment stopped. This may make it an option for women of childbearing age who are excluded from other retinoids due to the risk of these drugs causing severe birth defects. In a conference presentation on psoriasis treatment, Jeffrey Weinberg, M.D., assistant professor at New York Medical College commented, "There is a negligible amount of oral tazarotene in the body after seven days, which offers hope that women will be able to conceive one month after discontinuation of therapy."
Allergan, oral Tazorac's manufacturer, filed for U.S. Food and Drug Administration approval in November 2003. Allergan hopes to have approval for the drug by the end of the year.
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