Oral combination drug formulation comprising a non-steroidal anti-inflammatory drug and a complementary low dose of tranexamic acid for the treatment of menstrual pain accompanied with excessive menstrual blood loss

Abstract

A method for relieving menstrual pain and reducing menstrual blood loss in a female is provided. The method comprises administering to the female an oral combination drug formulation comprising a first therapeutically effective dose of a non-steroidal anti-inflammatory drug (NSAID) and a second complementary low dose of tranexamic acid, wherein the NSAID is formulated to relieve the menstrual pain and to reduce a volume of menstrual blood loss of the female, wherein the dose of tranexamic acid ranges from 50 mg to 425 mg per oral combination drug formulation.

What is claimed is: 
     
         1 . A method for relieving menstrual pain and reducing menstrual blood loss in a female comprising:
 administering to the female an oral combination drug formulation comprising a first therapeutically effective dose of a non-steroidal anti-inflammatory drug (NSAID) and a second complementary low dose of tranexamic acid, wherein the NSAID is formulated to relieve the menstrual pain and to reduce a volume of menstrual blood loss of the female, wherein the dose of tranexamic acid ranges from 50 mg to 425 mg per oral combination drug formulation.   
     
     
         2 . The method of  claim 1 , wherein a total daily dose of the tranexamic acid is any one of: does not exceed 2125 mg, does not exceed 1300 mg, and ranges from 600 mg to 1000 mg. 
     
     
         3 . The method of  claim 1 , wherein the oral combination drug formulation is in a form of any one of: an oral tablet, an oral capsule, and an oral caplet. 
     
     
         4 . The method of  claim 3 , wherein the NSAID comprises any one of:
 ibuprofen, naproxen, diclofenac, ketoprofen, mefenamic acid, and metabolites thereof.   
     
     
         5 . The method of  claim 4 , wherein the dose of the NSAID per oral combination drug formulation ranges from 5 mg to 1000 mg. 
     
     
         6 . The method of  claim 5 , wherein the dose of the NSAID per oral combination is any one of: from 100 mg to 800 mg of the ibuprofen, from 150 mg to 600 mg of the naproxen, from 5 mg to 50 mg of the diclofenac, from 5 mg to 50 mg of the ketoprofen, and from 50 mg to 500 mg of the mefenamic acid. 
     
     
         7 . The method of  claim 1 , wherein the female has a condition that comprises any one of: primary dysmenorrhea, secondary dysmenorrhea, menorrhagia, idiopathic menorrhagia, cyclic heavy menstrual bleeding, dysfunctional uterine bleeding, anemia, menstrual bleeding of less than 80 ml per menstrual cycle, and menstrual bleeding of more than 80 ml per menstrual cycle. 
     
     
         8 . The method of  claim 1 , wherein the oral combination drug formulation is administered: from the onset of menstrual bleeding until the resolution of related symptoms; from the onset of menstrual bleeding until the end of the menstrual period; or one to six times per day. 
     
     
         9 . A method for relieving menstrual pain and reducing menstrual blood loss in a female comprising:
 administering to the female an oral combination drug formulation comprising a first therapeutically effective dose of a non-steroidal anti-inflammatory drug (NSAID) and a second complementary low dose of tranexamic acid, wherein the NSAID is formulated to relieve menstrual pain and to reduce a volume of the menstrual blood loss, wherein a total daily dose and a dose per oral combination drug formulation of tranexamic acid is selected based on a contribution of the NSAID to the reduction of menstrual blood loss.   
     
     
         10 . The method of  claim 9 , wherein the dose of the tranexamic acid per oral combination drug formulation ranges from 50 mg to 425 mg. 
     
     
         11 . The method of  claim 9 , wherein the total daily dose of the tranexamic acid is selected: a) based on the difference between a desired percent reduction in menstrual blood loss and a percent reduction in the menstrual blood loss achievable with the selected dose of the NSAID; and b) based on assumptions that (i) efficacy of the tranexamic acid in reduction of menstrual blood loss is dose-dependent and that (ii) approximately 40% reduction of menstrual blood loss is achievable with a daily dose of 3900 mg of the tranexamic acid, when used without NSAID. 
     
     
         12 . The method of  claim 9 , wherein the oral combination drug formulation administration results in any one of: at least 40% decrease in the menstrual blood loss when administered to the female having menorrhagia; and at least 25% decrease in menstrual blood loss when administered to the female with no clinical diagnosis related to menorrhagia. 
     
     
         13 . The method of  claim 9 , wherein the total daily dose of the tranexamic acid is any one of: from 600 mg to 1000 mg, 800 mg, 650 mg, and from 390 mg to 585 mg. 
     
     
         14 . The method of  claim 9 , wherein the NSAID has any one of: proven analgesic efficacy and an indication for the treatment of menstrual pain. 
     
     
         15 . The method of  claim 9 , wherein the NSAID comprises any one of:
 ibuprofen, naproxen, diclofenac, ketoprofen, mefenamic acid, and metabolites thereof.   
     
     
         16 . The method of  claim 10 , wherein the dose of the tranexamic acid per oral combination drug formulation is any one of: from 150 mg to 250 mg, and from 250 mg to 300 mg. 
     
     
         17 . The method of  claim 15 , wherein the oral combination drug formulation comprises 400 mg of the ibuprofen and 150-200 mg of the tranexamic acid, wherein the oral combination drug formulation is administered four times daily to the female clinically diagnosed with primary or secondary dysmenorrhea and clinically diagnosed with menorrhagia. 
     
     
         18 . The method of  claim 15 , wherein the oral combination drug formulation comprises 200 mg of the ibuprofen and from 200 mg to 250 mg of the tranexamic acid, wherein the oral combination drug formulation is administered three times daily to treat the female with no clinical diagnosis related to dysmenorrhea and menorrhagia. 
     
     
         19 . An orally administrable pharmaceutical composition, comprising:
 a first therapeutically effective dose of a non-steroidal anti-inflammatory drug (NSAID), and a second complementary dose of tranexamic acid, wherein the dose of the NSAID is formulated to reduce menstrual pain and to reduce a volume of the menstrual blood loss, wherein the total daily dose and the dose of tranexamic acid per the pharmaceutical composition is selected based on the contribution of the NSAID to the reduction of the menstrual blood loss.   
     
     
         20 . The composition of  claim 19 , wherein a dose of the tranexamic acid per the pharmaceutical composition is any one of: from 150 mg to 250 mg and from 250 mg to 300 mg. 
     
     
         21 . The composition of  claim 19 , wherein the composition is formulated as any one of: an oral tablet, an oral capsule, and an oral caplet. 
     
     
         22 . The composition of  claim 19 , wherein the NSAID has any one of: proven analgesic efficacy and an indication for the treatment of menstrual pain. 
     
     
         23 . The composition of  claim 19 , wherein the NSAID comprises any one of:
 ibuprofen, naproxen, diclofenac, ketoprofen, mefenamic acid, and metabolites thereof.   
     
     
         24 . The composition of  claim 23 , wherein the composition comprises any one of: 400 mg of the ibuprofen and 150-200 mg of the tranexamic acid; 200 mg of the ibuprofen and the 200-250 mg of the tranexamic acid; 500 mg of the mefenamic acid and 150-200 mg of the tranexamic acid; 500 mg of the mefenamic acid and 250-300 mg of the tranexamic acid.