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Clinical trials show improvement for moderate to severe psoriasis
First posted Dec. 3, 2003
Allergan announced on Wednesday that the company filed for U.S. Food and Drug Administration (FDA) approval for oral tazarotene, a version of Tazorac, a drug approved for topical use for psoriasis in 1997. The drug is a retinoid, which is a derivative of vitamin A. It was shown in late-stage trials to be effective as an oral capsule for the treatment of moderate to severe psoriasis.
The combined analysis of two phase III trials involved 690 patients taking 4.5 milligrams of tazarotene daily for 12 weeks, followed by 12 weeks of follow-up. More than half the patients taking oral tazarotene saw their psoriasis symptoms improve by 50 percent, and 30 percent improved at least 75 percent. Significant improvements were maintained during the follow-up period. Fewer than 5 percent of treated patients discontinued therapy due to side effects. The main side effects were inflammation and cracking of the lips, dry skin, headache, and aches and pains.
"Oral retinoids have been one of the most valuable treatments for patients with severe psoriasis," said Dr. Steven Feldman, Director of the Psoriasis Treatment Center at the Wake Forest University School of Medicine. "By reducing the scaliness and thickness of lesions, oral retinoids make our topical and photo therapies much more effective. The introduction of oral tazarotene gives us another good options for patients, especially those who had difficulty with side effects of older oral retinoids."
"I intend to use oral tazarotene along with UVB phototherapy for plaque psoriasis and for pustular psoriasis of the palms and soles. I do hope that the low irritation/side effect rate seen in the clinical trials also holds up in clinical practice."
According to Allergan, the drug clears from the body within 7 to 12 hours. The company has submitted a label that will now be scutinized by the FDA. The company is recommending that women of childbearing potential wait one menstrual cycle before attempting to conceive-a shorter waiting period than with other oral vitamin A derivatives. Allergan hopes to have approval of the drug by the fourth quarter of 2004.
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