US 8,299,109 B2Granted

Method of treating actinic keratosis with 3.75% imiquimod cream

AssigneeMedicis Pharmaceutical Corporation

InventorsMichael T. Nordsiek, Sharon F. Levy, James H. Lee, James H. Kulp, Kodumudi S. Balaji, Tze-Chiang Meng, Jason J. Wu, Valyn S. Bahm, Robert Babilon

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Abstract

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.

Claims15

Dependent claims

A method for treating actinic keratosis (AK) in an immunocompetent adult in need thereof, comprising:

(a) topically applying once daily a 3.75% (w/w) imiquimod composition to the full face or balding scalp of the patient for a first two-week treatment period, wherein the topically applied imiquimod composition is applied to the full face or balding scalp and rubbed in until no longer visible, left on the full face or balding scalp for about eight hours and then removed from the full face or balding scalp by washing;
and
(b) topically applying once daily a 3.75% (w/w) imiquimod composition to the full face or balding scalp of the patient for a second two-week treatment period, wherein the topically applied imiquimod composition is applied and rubbed in until no longer visible, left on the full face or balding scalp for about eight hours and then removed from the full face or balding scalp by washing;
wherein the first treatment period and the second treatment period are separated by one, two-week non-treatment period during which no imiquimod is applied;
wherein the method of treating actinic keratoses is completed in six weeks;
and wherein in performance of the method, the imiquimod is the sole active pharmaceutical ingredient required to be applied to the full face or balding scalp.

3 more elements

Dependencies are inferred from the claim text.

Facts

Application: 13/182,433Filed 13 Jul 2011 · continuation
Priority: 19 Dec 2008
Published: US 2011/0021555 A127 Oct 2011
Granted: 30 Oct 2012
Term ends: Not estimatedThe source records don’t support an estimate.

Classification15 codes

A61K 31/4745
Ortho- or peri-condensed with heterocyclic ring systems: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
A61K 9/0014
Galenical forms characterised by the site of application: skin, i.e. galenical aspects of topical compositions
A61K 9/06
Medicinal preparations characterised by special physical form: ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
A61K 9/7061
Obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene: polyacrylates

Family

Application61/139,536Us provisional application · filed 19 Dec 2008
Application61/144,731Us provisional application · filed 14 Jan 2009
Application61/205,145Us provisional application · filed 15 Jan 2009
Application12/636,613Parent of this continuation · filed 11 Dec 2009
US 2011/0263635 A1Pre-grant publication · published 27 Oct 2011
US 2011/0021555 A1Published application
US 8,242,155 B2Related patent
US 8,299,109 B2This patent

From the US filing history. Foreign family members aren’t listed.