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Claims for Patent: 9,339,499

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Claims for Patent: 9,339,499

Title:Treating pain in patients with hepatic impairment
Abstract: An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.
Inventor(s): Hartman; Andrew (Belmont, CA), Rubino; Christopher M. (Williamsville, NY), Robinson; Cynthia Y. (Burlingame, CA)
Assignee: Pernix Ireland Pain Limited (Dublin, IE)
Application Number:14/978,217
Patent Claims: 1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising: administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, wherein the dosage unit provides a release profile of hydrocodone that: does not increase average hydrocodone AUC.sub.0-inf in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%; and does not increase average hydrocodone AUC.sub.0-inf in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 30%.

2. The method of claim 1, wherein the dosage unit comprises 15 mg or more of hydrocodone bitartrate.

3. The method of claim 1, wherein the dosage unit comprises 20, 30 or 40 mg of hydrocodone bitartrate.

4. The method of claim 1, wherein the dosage unit further comprises an immediate-release formulation of hydrocodone bitartrate.

5. The method of claim 4, wherein the extended release formulation of the dosage unit comprises 75% to 85% by weight of the total hydrocodone in the dosage unit and the immediate release formulation of the dosage unit comprises 15% to 25% by weight of the total hydrocodone in the dosage unit.

6. The method of claim 4, wherein the dosage unit comprises a first population of beads comprising the immediate release formulation of hydrocodone bitartrate and a second population of beads comprising the extended release formulation of hydrocodone bitartrate.

7. The method of claim 1, wherein the dosage unit provides a release profile of hydrocodone that does not increase average hydrocodone C.sub.max in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 25%, and the release profile of hydrocodone does not increase average hydrocodone C.sub.max in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 30%.

8. The method of claim 1, wherein the dosage unit provides a release profile of hydrocodone that does not increase average hydrocodone C.sub.max in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 9%, and the release profile of hydrocodone does not increase average hydrocodone C.sub.max in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%.

9. The method of claim 1, wherein the dosage unit provides a release profile of hydrocodone such that: (1) the average hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects not suffering from renal or hepatic impairment is in the range of about 300 ng*h/mL to about 500 ng*h/mL; (2) the average hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects suffering from mild hepatic impairment is in the range of about 300 ng*h/mL to about 570 ng*h/mL; and (3) the average hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects suffering from moderate hepatic impairment is in the range of about 300 ng*h/mL to about 700 ng*h/mL.

10. The method of claim 9, wherein the dosage unit provides a release profile of hydrocodone such that the average hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects not suffering from renal or hepatic impairment is in the range of about 317 ng*h/mL to about 465 ng*h/mL.

11. The method of claim 9, wherein the dosage unit provides a release profile of hydrocodone such that the average hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects suffering from mild hepatic impairment is in the range of about 316 ng*h/mL to about 564 ng*h/mL.

12. The method of claim 9, wherein the dosage unit provides a release profile of hydrocodone such that the average hydrocodone AUC.sub.0-inf per 20 mg of hydrocodone bitartrate dosed to subjects suffering from moderate hepatic impairment is in the range of about 352 ng*h/mL to about 666 ng*h/mL.

13. The method of claim 9, wherein the dosage unit provides a release profile of hydrocodone such that the average hydrocodone C.sub.max per 20 mg of hydrocodone bitartrate dosed to subjects not suffering from renal or hepatic impairment is in the range of about 17 ng/mL to about 27 ng/mL.

14. The method of claim 9, wherein the dosage unit provides a release profile of hydrocodone such that the average hydrocodone C.sub.max per 20 mg of hydrocodone bitartrate dosed to subjects suffering from mild hepatic impairment is in the range of about 19 ng/mL to about 29 ng/mL.

15. The method of claim 9, wherein the dosage unit provides a release profile of hydrocodone such that the average hydrocodone C.sub.max per 20 mg of hydrocodone bitartrate dosed to subjects suffering from moderate hepatic impairment is in the range of about 20 ng/mL to about 30 ng/mL.

16. The method of claim 1, wherein the dosage unit is formulated to release about 10% to about 30% of the hydrocodone in a first hour and release about 60% to about 98% of the hydrocodone during a first 12 hours after placement in a USP dissolution apparatus buffered at a pH of 6.8.

17. A method of treating pain in a patient having mild hepatic impairment, the method comprising: administering to the patient having mild hepatic impairment a starting dose of an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, and wherein the starting dose is not adjusted relative to a patient without hepatic impairment.

18. The method of claim 17, wherein the dosage unit comprises 15, 20, 30 or 40 mg of hydrocodone bitartrate.

19. A method of treating pain in a patient having moderate hepatic impairment, the method comprising: administering to the patient having moderate hepatic impairment a starting dose of an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, and wherein the starting dose is not adjusted relative to a patient without hepatic impairment.

20. The method of claim 19, wherein the dosage unit comprises 15, 20, 30 or 40 mg of hydrocodone bitartrate.
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