Patent ID: 9326982
Filing Date: 2016-05-03
CPC Classification: A61K

Claim Text:
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 a starting dose of an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the starting dose is not adjusted relative to a patient without hepatic impairment; wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate; wherein the dosage unit is formulated to release about 10% to about 30% of the hydrocodone in a first hour and release more than about 60% and less than about 98% of the hydrocodone during a first 12 hours after placement in a USP dissolution apparatus buffered at a pH of 6.8; wherein the dosage unit provides a release profile of hydrocodone such that the average hydrocodone AUC wherein the dosage unit provides a release profile of hydrocodone such that the average hydrocodone C