Medicis Pharmaceutical Corporation

Sharon F Levy

Michael T Nordsiek

Kodumudi S Balaji

Tze-Chiang Meng

Jason J Wu

James H Kulp

Robert Babilon

Valyn S Bahm

James H Lee

James Hurn-Joung Lee

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-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 actinic keratosis with short durations of therapy, than currently prescribed for the commercially available Aldara&#xae; 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 actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration ('FDA') for Aldara&#xae; 5% imiquimod cream to treat actinic keratosis are also disclosed and described.

2x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod

2&#xd7;2&#xd7;2 week dosing regimen for treating acting keratosis with pharmaceutical compositions formulated with 3.75% imiquimod

2&#xd7;2&#xd7;2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod

Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-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 actinic keratosis with short 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 actinic keratosis with an acceptable safety profile and dosing regimens that are short 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 actinic keratosis are also disclosed and described.

Method of treating actinic keratosis with 3.75% imiquimod cream

2&#xd7;2&#xd7;2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod

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Philadelphia, PA, United States of America

Sharon F Levy