Claims for Patent: 8,945,621

Summary for Patent: 8,945,621

Title:	Method for treating a patient at risk for developing an NSAID-associated ulcer
Abstract:	The present disclosure is directed to a method for treating a disease or disorder in a patient at risk of developing an NSAID-associated ulcer by administering to said patient in need thereof a pharmaceutical composition in unit dose form comprising naproxen, or pharmaceutically acceptable salt thereof, and esomeprazole, or pharmaceutically acceptable salt thereof to said at risk patient and thereby decreasing the patient's risk of developing an ulcer.
Inventor(s):	Ault; Brian (Wilmington, DE), Hwang; Clara (Wilmington, DE), Orlemans; Everardus (Chapel Hill, NC), Plachetka; John R (Chapel Hill, NC), Sostek; Mark (Wilmington, DE)
Assignee:	Pozen Inc. (Chapel Hill, NC) Horizon Pharma USA, Inc. (Deerfield, IL)
Application Number:	12/822,612
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,945,621
Patent Claims:	1. A method of reducing the incidence of NSAID-associated gastric ulcers in patients taking low dose aspirin who are at risk of developing such ulcers, wherein the method comprises administering to said patient in need thereof a pharmaceutical composition in unit dose form comprising: (a) 20 mg of esomeprazole, or pharmaceutically acceptable salt thereof, in a form and route sufficient to raise the gastric pH of said patient to at least 3.5 upon administration of one or more of said unit dose forms, and (b) 500 mg of naproxen, or pharmaceutically acceptable salt thereof; wherein said unit dose form provides for coordinated release of the esomeprazole and the naproxen, wherein at least a portion of said esomeprazole, or pharmaceutically acceptable salt thereof, is released independent of the pH of the surrounding medium, wherein the unit dosage form releases less than 10% of the naproxen or a pharmaceutically acceptable salt thereof after 2 hours when tested using the USP Paddle Method in 1000 ml of 0.1N HCl at 75 rpm at 37.degree. C.+/-0.5.degree. C., wherein said pharmaceutical composition in unit dose form reduces the incidence of NSAID-associated ulcers in said patient and wherein administration of the unit dose form is more effective at reducing the incidence of the NSAID-associated ulcers in patients taking LDA than in patients not taking LDA who are administered the unit dose form. 2. The method according to claim 1, wherein the risk is associated with chronic NSAID treatment. 3. The method according to claim 1, wherein said patient is treated for a disease or disorder selected from pain and inflammation. 4. The method according to claim 1, wherein said patient is treated for a disease or disorder selected from osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and a combination thereof. 5. The method according to claim 1, wherein said unit dose form is at least about 95% free of sodium bicarbonate. 6. The method according to claim 1, wherein said unit dose form begins to release said naproxen, or a pharmaceutically acceptable salt thereof, when the pH of the surrounding medium is at about 4.0 or greater. 7. The method according to claim 1, wherein said unit dose form begins to release said naproxen, or a pharmaceutically acceptable salt thereof, when the pH of the surrounding medium is at about 4.5 or greater. 8. A method of reducing the incidence of NSAID-associated gastric ulcers in patients taking low dose aspirin who are at risk of developing such ulcers, wherein the method comprises administering to the patient a pharmaceutical composition in unit dosage form suitable for oral administration comprising: (a) 20 mg of esomeprazole or a pharmaceutically acceptable salt thereof, that is immediately soluble when the dosage form is placed in an aqueous medium, independent of pH, in an amount effective to raise the gastric pH of the patient to at least 3.5 upon administration of one or more of the unit dosage forms, and (b) 500 mg of naproxen or pharmaceutically acceptable salt thereof, wherein the unit dosage form releases less than 10% of the naproxen or a pharmaceutically acceptable salt thereof after 2 hours when tested using the USP Paddle Method in 1000 ml of 0.1N HCl at 75 rpm at 37.degree. C.+/-0.5.degree. C.; wherein said pharmaceutical composition in unit dose form reduces the incidence of NSAID-related ulcers in said patient and wherein administration of the unit dose form is more effective at reducing the incidence of the NSAID-associated ulcers in patients taking LDA than in patients not taking LDA who are administered the unit dose form. 9. The method of claim 8, wherein the risk is associated with chronic NSAID treatment. 10. The method of claim 8, wherein the patient is treated for a disease or disorder selected from pain, inflammation, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and combinations thereof. 11. The method of claim 8, wherein the pharmaceutical composition is formulated to be administered to a patient twice daily. 12. The method according to claim 8, wherein the unit dosage form further comprises a pharmacologically inert, water soluble coating or film. 13. The method of claim 12, wherein the inert coating or film comprises a water soluble sugar. 14. The method of claim 8, wherein administration of the unit dosage form is more effective at reducing the risk of ulcer than treatment with enteric coated naproxen or a pharmaceutically acceptable salt thereof. 15. A method of reducing the incidence of NSAID-associated gastric ulcers in patients taking low dose aspirin (LDA) who are at risk of developing such ulcers, wherein the method comprises administering to said patient in need thereof twice a day for 1 month a pharmaceutical composition in unit dose form comprising: (a) 20 mg of esomeprazole, or pharmaceutically acceptable salt thereof, in a form and route sufficient to raise the gastric pH of said patient to at least 3.5 upon administration of one or more of said unit dose forms, and (b) 500 mg of naproxen, or pharmaceutically acceptable salt thereof; wherein said unit dose form provides for coordinated release of the esomeprazole and the naproxen, wherein at least a portion of said esomeprazole, or pharmaceutically acceptable salt thereof, is released independent of the pH of the surrounding medium, wherein the unit dosage form releases less than 10% of the naproxen or a pharmaceutically acceptable salt thereof after 2 hours when tested using the USP Paddle Method in 1000 ml of 0.1N HCl at 75 rpm at 37.degree. C.+/-0.5.degree. C., and wherein administration of the unit dose form is more effective at reducing the incidence of the NSAID-associated gastric ulcers in patients taking LDA than in patients not taking LDA who are administered the unit dose form. 16. A method of reducing the incidence of NSAID-associated gastric ulcers in patients taking low dose aspirin (LDA) who are at risk of developing such ulcers, wherein the method comprises administering to said patient in need thereof twice a day for 3 months a pharmaceutical composition in unit dose form comprising: (a) 20 mg of esomeprazole, or pharmaceutically acceptable salt thereof, in a form and route sufficient to raise the gastric pH of said patient to at least 3.5 upon administration of one or more of said unit dose forms, and (b) 500 mg of naproxen, or pharmaceutically acceptable salt thereof; wherein said unit dose form provides for coordinated release of the esomeprazole and the naproxen such that: wherein at least a portion of said esomeprazole, or pharmaceutically acceptable salt thereof, is released independent of the pH of the surrounding medium, wherein the unit dosage form releases less than 10% of the naproxen or a pharmaceutically acceptable salt thereof after 2 hours when tested using the USP Paddle Method in 1000 ml of 0.1N HCl at 75 rpm at 37.degree. C.+/-0.5.degree. C., and wherein administration of the unit dose form is more effective at reducing the incidence of said ulcers in patients taking LDA than in patients not taking LDA who are administered the unit dose form.