FDA provides testing options for oral tazarotene
Company may have opportunity to resubmit oral retinoid for approval
Posted June 8, 2005
The U.S. Food and Drug Administration presented options for Allergan, Inc. on June 1, 2005, for testing its psoriasis drug oral tazarotene. The FDA had voted against approval of the drug last fall, citing incomplete safety precautions.
The company believes it can fund and complete the study in a reasonable amount of time, and will provide more details about a development plan once an agreement has been reached with the FDA. Allergan also plans to provide some additional pharmacokinetic (how the drug works) and toxicology (the potential adverse effects) data to the FDA.
Oral tazarotene is taken as a once daily oral medication. It is a vitamin A derivative, or retinoid, that selectively targets two receptors in the skin. An advantage of oral tazarotene is that it clears out of the bloodstream significantly faster than other retinoids. 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.
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, retinoids can cause serious birth defects if they are present in a woman's body before or during pregnancy.
In 2004, Allergan presented evidence about oral tazarotene's efficacy and safety, and agreed to a proposed risk management program to track patient, physician and pharmacy compliance. However, the FDA advisory committee expressed concern over reports of bone mineral density loss, and potential off-label use of the drug for acne and the chance of pregnancy.
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