Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts

Abstract

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat genital/perianal warts are also disclosed and described.

1 - 55 . (canceled) 
     
     
         56 . A method of achieving hill clearance of genital or perianal warts in a subject in need thereof comprising identifying a subject suffering from at least a wart in the genital or perianal region, topically applying to the region a pharmaceutical cream comprising about 3.75% w/w imiquimod as the sole active ingredient, continuing the application of the cream once daily for a period of up to 8 weeks, and achieving full clearance of the wart at the region. 
     
     
         57 . The method of  claim 56 , wherein full clearance is achieved prior to the 8 week period. 
     
     
         58 . The method of  claim 56 , wherein about 9.3 mg of imiquimod is applied daily. 
     
     
         59 - 61 . (canceled)