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The latest news releases from the National Psoriasis Foundation on research developments into psoriasis and psoriatic arthritis, National Psoriasis Foundation events for its members and the public and other relevant happenings.
FDA panels will hear today from National Psoriasis Foundation speakers in support of new psoriasis drug
Group urges approval of oral tazarotene (Tazoral) to treat moderate to severe psoriasis
Portland, Ore., July 12, 2004--The vice chairman of the National Psoriasis Foundation Board of Trustees and two patient volunteers will testify today before the U.S. Food and Drug Administration (FDA) near Washington, D.C., in support of the drug oral tazarotene for the treatment of moderate to severe psoriasis. Psoriasis is an immune-mediated, chronic skin disease that leads to inflamed, scaly and often painful lesions that can cover part or all of a person's body.
The drug, manufactured by Allergan, is a new vitamin A derivative, or retinoid, that selectively targets two receptors in the skin, and that clears out of the bloodstream significantly faster than other retinoids.
"After more than 20 years struggling with psoriasis, I feel like a new man using this drug," said Tyrone Gorre, 45, a professional fishing guide and ranch hand from Newcastle, California, who will testify today about his experience in an oral tazarotene clinical trial. "This medication has not only improved my physical health, it has given me back my self-confidence."
Tazoral is taken as a once daily oral medication in a 4.5 mg dose. It should not be confused with Tazorac, which is a topical retinoid available in gel and cream formulations that has been available since 1997 for the treatment of psoriasis.
While there are several treatments currently available for moderate to severe psoriasis, no single treatment works for everyone. Many people remain without satisfactory relief and are in urgent need of additional treatment options. More than five million Americans have psoriasis, and an estimated 1.5 million have moderate to severe psoriasis.
"As a parent of a teenager with psoriasis, I am looking forward to testifying today about the urgent need psoriasis patients have for additional treatment options," said Dale White, of Poolesville, Maryland, vice chairman of the National Psoriasis Foundation Board of Trustees. "By expanding the choices available to treat this serious disease, we empower patients to choose the treatment that works best for them."
In clinical trials, patients using oral tazarotene exhibited tolerable short-term side effects, but as with any new medication, the long-term side effects are yet unknown. However, because retinoids can cause serious birth defects if they are present in a woman's body while she is pregnant, the Psoriasis Foundation supports use of a risk management program for oral tazarotene focused on women of child-bearing potential, to minimize to the greatest extent feasible the likelihood that a woman will become pregnant while taking this drug.
Today's hearing will be conducted jointly by the Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, independent committees of experts that review and evaluate available data on drug safety and effectiveness and make recommendations to the FDA. The FDA generally follows these recommendations, but is not required to do so.
"Psoriasis is a terrible disease to live with, but this medication offers those of us with psoriasis cause for hope," Gorre said.
About Psoriasis
Psoriasis is a lifelong skin disease that occurs when faulty signals in the immune system cause skin cells to regenerate too quickly—every three to four days instead of the usual 30-day cycle. Extra skin cells build up on the skin—s surface, forming red, flaky, scaly lesions that can itch, crack, bleed and be extremely painful. Psoriasis generally appears on the joints, limbs and scalp but it can appear anywhere on the body, covering some people from head to toe. More than 5 million Americans have psoriasis and/or psoriatic arthritis, a degenerative disease of the joints and connective tissues associated with psoriasis. Psoriasis typically first strikes people between the ages of 15 and 35, but can affect anyone at any age, including children.
About the National Psoriasis Foundation
The National Psoriasis Foundation is the leading nonprofit organization fighting to improve the quality of life of the more than 5 million Americans diagnosed with psoriasis and/or psoriatic arthritis and their families. Its mission is to educate people about these diseases and their treatments, raise public awareness, and support ongoing research. The organization is headquartered in Portland, Ore. For more information, please call the Psoriasis Foundation at 800.723.9166 or visit http://www.psoriasis.org.
Media inquiries:
Marketing and Communications Department
National Psoriasis Foundation
503.244.7404, ext. 413
pfasano@psoriasis.org
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