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 (â€œFDAâ€ ), 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 (â€œFDAâ€ ) for ALDARA 5% imiquimod cream to treat actinic keratosis are also disclosed and described.

Claims

15 · 1 independent · depth 4

15 granted claims

›1.independentA method for treating actinic keratosis (AK) in an immunocompetent adult in need thereof, comprising:n(a) topically applying once daily a 3.75% (w/w) …+14

›2.↳ 1The method of claim 1, wherein 250-500 mg of the imiquimod composition is applied.d2

›3.↳ 1The method of claim 1, wherein at least 9.3 mg up to 18.8 mg of imiquimod is applied daily during the two-week treatment periods.d2

›4.↳ 1The method of claim 1, wherein at least 65.6 mg up to 131.3 mg of imiquimod is applied weekly during the two-week treatment periods.d2

›5.↳ 1The method of claim 1, wherein at least 131.2 mg up to 262.5 mg of imiquimod is applied during the two-week treatment periods.d2

›6.↳ 1The method of claim 1, wherein at least 262.5 mg up to 525 mg of imiquimod is applied on a 6-week treatment course.d2

›7.↳ 1The 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 immun…d2+2

›10.↳ 1The method of claim 1, wherein the AK is clinically typical, visible or palpable.d2

›11.↳ 1The method of claim 1, wherein applying the 3.75% imiquimod composition continues in each one of the two-week treatment periods even if no actinic ker…d2

›12.↳ 1The method of claim 1, wherein the 3.75% imiquimod composition is applied to the full face.d2

›13.↳ 1The method of claim 1, wherein the 3.75% imiquimod composition is applied to the balding scalp.d2

›14.↳ 1The method of claim 1, wherein the full face is at least 200-250 cm2.d2

›15.↳ 1The 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 o…d2

Classifications

4 codes

IPC · International Patent Classification

Section A — Human necessities

A01N43/42
A01N43/52

USPC · US Patent Classification

514/393514/290

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Pendency

1.1 y

398 days filing → grant

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non-final + final

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2 RCE

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Kendra D Carter

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2 priority documents

Priority

19 Dec 2008

earliest claimed

›Priority documents — 2

Type	Document	Date
provisional	US 61139536	19 Dec 2008
related publication	US 20110263635 A1	27 Oct 2011

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