LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS

摘要

The present invention relates to a cream for treating a subject diagnosed with genital or perianal warts, comprising about 3.75 wt.% of 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine (imiquimod) and a pharmaceutically acceptable vehicle for the imiquimod, wherein the vehicle comprises a fatty acid, wherein the fatty acid is selected from the group consisting of palmitic acid, linoleic acid, stearic acid, isostearic acid, unrefined oleic acid, super refined oleic acid, and mixtures thereof, and wherein each 250 mg of the cream contain 9.375 mg of the imiquimod. Furthermore, the present invention relates to a method of treating a subject diagnosed with genital or perianal warts, wherein the duration of therapy is 8 weeks or less, and wherein the method comprises topical applying the claimed cream to a treatment area diagnosed with the genital or perianal warts and removing it in about 8 hours once a day for up to 8 following weeks or until complete wart clearance, depending on what occurs first, wherein up to 9.375 mg of the imiquimod is applied daily.