Claims for Patent: 11,318,130

Summary for Patent: 11,318,130

Title:	2x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
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.RTM. 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.RTM. 5% imiquimod cream to treat actinic keratosis are also disclosed and described.
Inventor(s):	Nordsiek; Michael T. (Wayne, PA), Levy; Sharon F. (Philadelphia, PA), Lee; James Hurn-Joung (St. Paul, MN), Kulp; James H. (West Chester, PA), Balaji; Kodumudi S. (Lansdale, PA), Meng; Tze-Chiang (Lino Lakes, MN), Wu; Jason J. (Wayne, PA), Bahm; Valyn S. (Phoenixville, PA), Babilon; Robert (Boyertown, PA)
Assignee:	Medicis Pharmaceutical Corporation (Bridgewater, NJ)
Application Number:	16/268,230
Patent Claims:	1. A method of treating actinic keratoses (AK) in an immunocompetent adult patient in need thereof in a six week treatment course, the method comprising: (a) topically applying a 2.5% (w/w) imiquimod composition once daily to the full face or balding scalp of the immunocompetent adult patient over a first two-week treatment period; and (b) topically applying a 2.5% (w/w) imiquimod composition once daily to the full face or balding scalp of the immunocompetent adult patient over a second two-week treatment period; and 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 to the immunocompetent adult patient; wherein the 2.5% (w/w) imiquimod composition is a cream; and wherein the method of treating actinic keratoses is completed in six weeks. 2. The method of claim 1, wherein 250-500 mg of the imiquimod composition is applied. 3. The method of claim 1, wherein at least 6.25 mg to 12.5 mg of imiquimod is applied daily during the two-week treatment periods. 4. The method of claim 1, wherein at least 43.75 mg to 87.5 mg of imiquimod is applied weekly during the two-week treatment periods. 5. The method of claim 1, wherein at least 87.5 mg to 175 mg of imiquimod is applied during the two-week treatment periods. 6. The method of claim 1, wherein at least 175 mg to 350 mg of imiquimod is applied on a 6-week treatment course. 7. The method of claim 1, wherein performance of the method results in complete clearance of the actinic keratoses in the full face or scalp of the immunocompetent adult. 8. The method of claim 7, wherein performance of the method in a population of immunocompetent adults in need thereof results in a statistically significant improvement in the percent of total clearance of actinic keratoses compared to treatment with placebo. 9. The method of claim 8, wherein performance of the method in the population of immunocompetent adults in need thereof results in about 25% or greater complete clearance of actinic keratoses in the immunocompetent adults in the population. 10. The method of claim 1, wherein the AK is clinically typical, visible or palpable. 11. The method of claim 1, wherein applying the 2.5% imiquimod composition continues in each one of the two-week treatment periods even if no actinic keratoses are visible. 12. The method of claim 1, wherein the 2.5% imiquimod composition is applied to the full face. 13. The method of claim 1, wherein the 2.5% imiquimod composition is applied to the balding scalp. 14. The method of claim 1, wherein the full face is at least 200-250 cm.sup.2. 15. The method of claim 1, wherein performance of the method results in the clearance of at least 75% of the actinic keratoses in the full face or scalp of the immunocompetent adult.