Dosage forms of rofecoxib and related methods

Abstract

The subject matter disclosed herein relates to novel doses and dosage forms of rofecoxib having a therapeutic benefit.

What is claimed is: 
     
         1 . A method for treating pain, fever, or inflammation in a human subject, the method comprising orally administering to the subject once daily a solid dosage formulation comprising 20 mg of rofecoxib. 
     
     
         2 . The method of  claim 1 , wherein the method comprises treating pain, fever, or inflammation associated with one or more of the following diseases or conditions: osteoarthritis (OA); rheumatoid arthritis (RA); pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis; acute pain; primary dysmenorrhea; migraine attacks with or without aura; chronic lower back pain; psoriatic arthritis; fibromyalgia; and hemophilic arthropathy. 
     
     
         3 . The method of  claim 1 , wherein the formulation achieves a mean Cmax plasma concentration of more than 191 ng/ml following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age. 
     
     
         4 . The method of  claim 1 , wherein the formulation achieves a mean plasma AUC 0-∞  of more than 3400 h*ng/ml following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age. 
     
     
         5 . The method of  claim 3 , wherein the formulation achieves a mean plasma AUC 0-∞  of more than 3400 h*ng/ml following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age. 
     
     
         6 . The method of  claim 1 , wherein the formulation achieves a mean plasma Cmax of 207-324 ng/ml following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age. 
     
     
         7 . The method of  claim 1 , wherein the formulation achieves a mean plasma AUC 0-∞  of 2840-4438 h*ng/ml following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age. 
     
     
         8 . The method of  claim 6 , wherein the formulation achieves a mean plasma AUC 0-∞  of 2840-4438 h*ng/ml following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age. 
     
     
         9 . The method of  claim 1 , wherein the formulation achieves a higher mean plasma Cmax and a higher mean plasma AUC 0-∞  in a population of healthy female adults less than 54 years of age compared to a population of healthy male adults less than 65 years of age following oral administration of a single dose of the formulation. 
     
     
         10 . The method of  claim 9 , wherein the mean plasma Cmax and the mean plasma AUC 0-∞  are at least 20% greater in the population of healthy female adults compared to the population of healthy male adults. 
     
     
         11 . The method of  claim 1 , wherein the formulation achieves a higher mean plasma AUC 0-∞  in Caucasian adults less than 65 years of age compared to healthy African American adults less than 65 years of age following oral administration of a single dose of the formulation. 
     
     
         12 . The method of  claim 1 , wherein the formulation achieves an arithmetic mean plasma concentration of at least 5.0 ng/ml at 15 minutes following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age. 
     
     
         13 . The method of  claim 12 , wherein the formulation achieves an arithmetic mean plasma concentration of about 5.7 ng/ml at 15 minutes following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age. 
     
     
         14 . The method of  claim 1 , wherein the formulation achieves an arithmetic mean plasma concentration of at least 112 ng/ml at 45 minutes following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age. 
     
     
         15 . The method of  claim 1 , wherein the formulation achieves an arithmetic mean plasma concentration of about 121 ng/ml at 45 minutes following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age 
     
     
         16 . The method of  claim 1 , wherein the formulation achieves a mean AUC following oral administration of a single dose of the formulation to a population of healthy adults less than 65 years of age that is comparable to the oral administration of a single 25 mg tablet of VIOXX to a population of healthy adults less than 65 years of age.