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Claims for Patent: 8,808,737

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Claims for Patent: 8,808,737

Title:Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Abstract: The invention pertains to a method of using oxymorphone in the treatment of pain by providing a patient with an oxymorphone dosage form and informing the patient or prescribing physician that the bioavailability of oxymorphone is increased in patients with renal impairment.
Inventor(s): Ahdieh; Harry (Lincoln University, PA)
Assignee: Endo Pharmaceuticals Inc. (Malvern, PA)
Application Number:12/716,973
Patent Claims: 1. A method of treating pain in a renally impaired patient, comprising the steps of: a. providing a solid oral controlled release dosage form, comprising: i. about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient; and ii. a controlled release matrix; b. measuring a creatinine clearance rate of the patient and determining it to be (a) less than about 30 ml/min, (b) about 30 mL/min to about 50 mL/min, (c) about 51 mL/min to about 80 mL/min, or (d) above about 80 mL/min; and c. orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief; wherein after said administration to said patient, the average AUC of oxymorphone over a 12-hour period is less than about 21 nghr/mL.

2. The method of claim 1, wherein the average AUC of oxymorphone over a 12-hour period is less than about 20 nghr/mL.

3. The method of claim 1, wherein the average AUC of oxymorphone over a 12-hour period is less than about 19 nghr/mL.

4. A method of treating pain in a renally impaired patient, comprising the steps of: a. providing a solid oral controlled release dosage form, comprising: i. about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient; and ii. a controlled release matrix; b. measuring a creatinine clearance rate of the patient and determining it to be (a) less than about 30 mL/min, (b) about 30 mL/min to about 50 mL/min, (c) about 51 mL/min to about 80 mL/min, or (d) above about 80 ml/min; and c. orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief; wherein after said administration to said patient, the Cmax of oxymorphone is less than about 1.4 ng/mL.

5. The method of claim 4, wherein the average Cmax of oxymorphone is less than about 1.3 ng/mL.

6. The method of claim 4, wherein the average Cmax of oxymorphone is less than about 1.2 ng/mL.
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