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

US8236816B2 · kind B2 · utility

Assignee

• MEDICON PHARMACEUTICALS, INC. · US

Inventors

• Michael T. Nordsiek · Wayne, US
• Sharon F. Levy · Philadelphia, US
• James H. Lee · Devon, US
• James H. Kulp · West Chester, US
• Kodumudi S. Balaji · Downingtown, US
• Tze-Chiang Meng · Lino Lakes, US
• Jason J. Wu · Wayne, US
• Valyn S. Bahm · Phoenixville, US
• Robert Babilon · Boyertown, US

Key dates

• Filing date: Jul 12, 2011
• Grant date: Aug 7, 2012
• Expiry date: Jul 12, 2031

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61P35/00
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

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.