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Claims for Patent: 6,683,102

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Claims for Patent: 6,683,102

Title: Methods of using metaxalone in the treatment of musculoskeletal conditions
Abstract:A method of increasing the bioavailability of metaxalone by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of metaxalone in a suitable container and associated with printed labeling which describes the increased bioavailability of the medication in the container when taken with food.
Inventor(s): Scaife; Michael (Poway, CA), Shah; Jaymin (Sunnyvale, CA)
Assignee: Elan Pharmaceuticals, Inc. (South San Francisco, GA)
Application Number:10/104,044
Patent Claims: 1. A method of using metaxalone in the treatment of musculoskeletal conditions comprising: providing the patient with a therapeutically effective amount of metaxalone; and informing the patient that the administration of metaxalone with food results in an increase in at least one of C(max) and AUC(last) of metaxalone compared to administration without food.

2. The method according to claim 1, wherein therapeutically effective amount of metaxalone comprises 200 mg to 900 mg of metaxalone.

3. The method according to claim 2, wherein the therapeutically effective amount of metaxalone comprises 400 mg to 800 mg of metaxalone.

4. The method according to claim 1, wherein the metaxalone is provided in tablet form.

5. The method according to claim 4, wherein the tablet is in unit dosage form.

6. A method of using metaxalone in the treatment of musculoskeletal conditions comprising: informing a patient with musculoskeletal conditions that the administration of a therapeutically effective amount of metaxalone with food results in an increase in at least one of C(max) and AUC(last) of metaxalone compared to administration without food.

7. A method of using metaxalone in the treatment of musculoskeletal conditions comprising altering the oral bioavailability of metaxalone by: obtaining metaxalone from a container providing information that administration of metaxalone with food increases at least one of C(max) and AUC(last) of metaxalone compared to administration without food, and ingesting the metaxalone with food.

8. A method of using metaxalone in the treatment of musculoskeletal conditions comprising: administering to a patient in need of treatment a therapeutically effective amount of metaxalone, with food, wherein the administration of the metaxalone with food results in an increase in at least one of C(max) and AUC(last) of metaxalone as compared to administration of metaxalone in a fasted state; and informing the patient that the administration of a therapeutically effective amount of metaxalone in a pharmaceutical composition with food results in an increase in at least one of C(max) and AUC(last) of metaxalone compared to administration in a fasted state.

9. The method according to claim 8, wherein the metaxalone is from a container with printed labeling advising that administration with food results in an increase in at least one of C(max) and AUC(last) of metaxalone compared to administration in a fasted state.

10. The method according to claim 9, wherein the metaxalone is provided in tablet form.

11. The method according to claim 10, wherein the metaxalone is provided in 400 mg tablet form.

12. The method according to claim 9, wherein the printed labeling advises that the administration of the metaxalone with food results in an increase in the C(max) of 177.5%.

13. The method according to claim 9, wherein the printed labeling advises that the administration of the metaxalone with food results in an increase in the AUC(last) of 123.5%.

14. The method according to claim 9, wherein the printed labeling further advises that the administration of the metaxalone with food results in an increase in AUC(inf) of 115.4%.

15. The method according to claim 8, wherein the metaxalone is provided in 400 mg tablet form, and the printed labeling advises that administration of metaxalone with food results in an increase in C(max), AUC(last), and AUC(inf), of 177.5%, 123.5%, and 115.4%, respectively, compared to administration of metaxalone in a fasted state.
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