IP Library Patent Application 13559456
Patent Application
App. No. 13/559,456

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

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Quick Facts
Patent No.
US None
App. No.
13/559,456
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 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.

Claims (5)

1 . A method of treating an external genital or perianal wart 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 wart once a day for up to eight consecutive weeks or until the wart is cleared, whichever occurs earlier;

wherein up to 9.375 mg of imiquimod is applied daily.

2 . The method of claim 1 , wherein up to 65.625 mg of imiquimod is applied weekly.

3 . The method of claim 1 , wherein up to 525 mg of imiquimod is applied in the eight week treatment period.

4 . The method of claim 1 , wherein up to 250 mg of the imiquimod composition is applied to the warts each day.