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.

1 - 61 . (canceled) 
     
     
         62 . A method of treating pain in a renally impaired patient with a creatinine clearance rate being less than about 80 mL/min, comprising the steps of:
 (a) providing the patient with a therapeutically effective amount of an oral dosage form of a pharmaceutical composition comprising from about 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof and a controlled release matrix;   (b) informing the patient or the patient's prescribing physician that the bioavailability of oxymorphone is increased in patients with renal impairment;   (c) orally administering the composition to the patient in a dose of oxymorphone or a pharmaceutically acceptable salt thereof that is less than the dose administered to a comparable patient without renal impairment wherein the dose depends on the creatinine clearance rate of the patient; and   (d) the administration of the composition to said renally impaired patient results in a comparable bioavailability of the oxymorphone to that of a healthy person.   
     
     
         63 . The method of  claim 62 , wherein the ratio of AUC of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to a comparable patient without renal impairment is about 0.86 to about 2.42 ng*hr/ml when administered equal doses. 
     
     
         64 . The method of  claim 62 , wherein the patient has mild renal impairment and the ratio of Cmax of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to a comparable patient without renal impairment is about 0.94 to about 2.03 ng/mL when administered equal doses. 
     
     
         65 . The method of  claim 64 , wherein the patient has mild renal impairment and the ratio of AUC of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to a comparable patient without renal impairment is about 0.86 to about 1.84 ng*hr/ml when administered equal doses. 
     
     
         66 . The method of  claim 62 , wherein the patient has moderate renal impairment and the ratio of Cmax of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to a comparable patient without renal impairment is about 1.12 to about 2.43 ng/mL when administered equal doses. 
     
     
         67 . The method of  claim 66 , wherein the patient has moderate renal impairment and the ratio of AUC of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to a comparable patient without renal impairment is about 1.07 to about 2.31 ng*hr/ml when administered equal doses. 
     
     
         68 . The method of  claim 62 , wherein the patient has severe renal impairment and the ratio of Cmax of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to a comparable patient without renal impairment is about 1.23 to about 2.65 ng/mL when administered equal doses. 
     
     
         69 . The method of  claim 68 , wherein the patient has severe renal impairment and the ratio of AUC of oxymorphone or pharmaceutically acceptable salt thereof in the renally impaired patient to a comparable patient without renal impairment is about 1.13 to about 2.42 when administered equal doses.