Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
AssigneeEndo Pharmaceuticals Inc.
InventorHarry Ahdieh
Life of this patent
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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.
Claims61
A method of treating pain in a renally impaired patient comprising administering a pharmaceutical composition comprising about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient and a controlled release matrix, wherein the renally impaired patient is administered a dose of oxymorphone or a pharmaceutically acceptable salt thereof that is less than the dose administered to a comparable patient without renal impairment, and wherein the log transformed AUC of oxymorphone is about 1.05 to about 2.45 times greater than the log transformed AUC of a healthy patient if the healthy patient were to be administered the same dose.
A method of treating pain in a renally impaired patient comprising administering a pharmaceutical composition comprising about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient and a controlled release matrix, wherein
- (a) the renally impaired patient is administered a dose of oxymorphone or a pharmaceutically acceptable salt thereof that is less than the dose administered to a comparable patient without renal impairment,
- (b) the creatinine clearance rate of the patient is determining it to be about 51 mL/min to about 80 mL/min, and
- (c) the renally impaired patient has mild renal impairment and the ratio of AUC of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to the comparable patient without renal impairment is about 0.86 to about 1.84 when administered equal doses.
Dependencies are inferred from the claim text.