LOWER DOSAGE STRENGTH IMIQUIMOD FORMULATIONS AND SHORT DOSING REGIMENS FOR TREATING GENITAL AND PERIANAL WARTS
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[4,5c]quinolin-4-amine, i.e., imiquimod, to treat genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available for 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 . A method of treating external genital or perianal warts in a patient 12 years old or older in need thereof in a treatment period of eight weeks or less, the method comprising topically applying a 3.75% (w/w) imiquimod composition to the genital or perianal warts once a day for up to eight consecutive weeks;
wherein the treatment achieves at least 75% percent clearance in the number of warts in the patient.
2 . The method of claim 1 , wherein up to 9.375 mg of imiquimod is applied daily.
3 . The method of claim 1 , wherein up to 65.625 mg of imiquimod is applied weekly.
4 . The method of claim 1 , wherein up to 525 mg of imiquimod is applied in the eight week treatment period.
5 . The method of claim 1 , wherein up to 250 mg of the imiquimod composition is applied to the warts each day.
6 . A method of treating external genital or perianal warts in a population of patients 12 years old or older in need thereof in a treatment period of eight weeks or less, the method comprising topically applying a 3.75% (w/w) imiquimod composition to the genital or perianal warts once a day for up to eight consecutive weeks;
wherein the treatment in a population results in less than 10% incidents of severe erythema.
7 . The method of claim 1 , wherein up to 9.375 mg of imiquimod is applied daily.
8 . The method of claim 1 , wherein up to 65.625 mg of imiquimod is applied weekly.
9 . The method of claim 1 , wherein up to 525 mg of imiquimod is applied in the eight week treatment period.
10 . The method of claim 1 , wherein up to 250 mg of the imiquimod composition is applied to the warts each day.