Novel 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 migraine associated with von Willebrand deficiency in a human subject, the method comprising administering to the subject a pharmaceutical composition comprising an effective amount of rofecoxib, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. 
     
     
         2 . The method of  claim 1 , wherein the effective amount is between about 10 mg and about 25 mg. 
     
     
         3 . The method of  claim 2 , wherein the effective amount is about 10 mg, about 10.5 mg, about 11 mg, about 11.5 mg, about 12 mg, about 12.5 mg, about 17.5 mg, about 20 mg, about 21 mg, about 22 mg, about 22.5 mg, or about 25 mg. 
     
     
         4 . The method of  claim 3 , wherein the effective amount is about 17.5 mg. 
     
     
         5 . The method of  claim 1 , wherein the effective amount is about 0.10 mg/kg, about 0.15 mg/kg, about 0.20 mg/kg, about 0.25 mg/kg, about 0.30 mg/kg, about 0.35 mg/kg, about 0.40 mg/kg, about 0.45 mg/kg, about 0.50 mg/kg, about 0.55 mg/kg, about 0.60 mg/kg, about 0.65 mg/kg, or about 0.70 mg/kg. 
     
     
         6 . The method of  claim 1 , wherein about 10 mg to about 70 mg of the rofecoxib, or a pharmaceutically acceptable salt thereof, is administered to the subject per day. 
     
     
         7 . The method of  claim 6 , wherein about 10 mg, about 10.5 mg, about 11 mg, about 11.5 mg, about 12 mg, about 12.5 mg, about 17.5 mg, about 20 mg, about 21 mg, about 21.5 mg, about 22.5 mg, about 25 mg, about 50 mg, about 60 mg, or about 70 mg of the rofecoxib, or a pharmaceutically acceptable salt thereof, is administered to the subject per day. 
     
     
         8 . The method of  claim 7 , wherein about 17.5 mg of the rofecoxib, or a pharmaceutically acceptable salt thereof, is administered to the subject per day. 
     
     
         9 . The method of  claim 1 , wherein the migraine is migraine without aura. 
     
     
         10 . The method of  claim 1 , wherein the migraine is migraine with aura. 
     
     
         11 . The method of  claim 1 , wherein the pharmaceutical composition is co-administered with factor replacement therapy. 
     
     
         12 . The method of  claim 1 , wherein the subject is being administered or is taking factor replacement therapy prophylactically. 
     
     
         13 . The method of  claim 1 , wherein the subject expresses von Willebrand factor at a level about 50% below normal. 
     
     
         14 . The method of  claim 1 , wherein the subject decreases or discontinues the use of acetaminophen and/or opioid medications during the course of the administration when compared to before the initiation of the administration. 
     
     
         15 . The method of  claim 1 , wherein the pharmaceutical composition is an oral dosage form. 
     
     
         16 . The method of  claim 15 , wherein the pharmaceutical composition is a solid oral dosage form. 
     
     
         17 . The method of  claim 16 , wherein the solid oral dosage form is a capsule, tablet, pill, dragee, powder, or granule. 
     
     
         18 . The method of  claim 15 , wherein the pharmaceutical composition is a liquid oral dosage formulation. 
     
     
         19 . The method of  claim 18 , wherein the liquid dosage form is an emulsion, microemulsion, solution, suspension, syrup, or elixir. 
     
     
         20 . The method of  claim 1 , wherein the subject is male. 
     
     
         21 . The method of  claim 1 , wherein the subject is female. 
     
     
         22 . The method of  claim 1 , wherein the subject is at least 18 years of age. 
     
     
         23 . The method of  claim 1 , wherein the subject is less than 65 years of age. 
     
     
         24 . The method of  claim 1 , wherein the treatment achieves a reduction of at least 1 from baseline in a Pain Intensity Numerical Rating Scale. 
     
     
         25 . The method of  claim 24 , wherein the treatment achieves a reduction of at least 2 from baseline in a Pain Intensity Numerical Rating Scale. 
     
     
         26 . The method of  claim 25 , wherein the treatment achieves a reduction of at least 3 from baseline in a Pain Intensity Numerical Rating Scale. 
     
     
         27 . The method of  claim 26 , wherein the treatment achieves a reduction of at least 4 from baseline in a Pain Intensity Numerical Rating Scale. 
     
     
         28 . The method of  claim 27 , wherein the treatment achieves a reduction of at least 5 from baseline in a Pain Intensity Numerical Rating Scale. 
     
     
         29 . The method of  claim 1 , wherein the pharmaceutical composition is administered to the subject once daily. 
     
     
         30 . The method of  claim 1 , wherein the pharmaceutical composition is administered to the subject two times or more daily.