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 - 20 . (canceled) 
     
     
         21 . A method of providing extended pain relief to patients in need thereof, comprising:
 providing information that the average bioavailability of oxymorphone in an oral extended release formulation designed to have a 12 hour dosing cycle is increased by at least about 26% for subjects with renal impairment compared to that for healthy subjects, and   providing a therapeutically effective amount of such an extended release oral dosage form of oxymorphone or its pharmaceutically acceptable salt thereof.   
     
     
         22 . The method of  claim 21  wherein in the information provided an average bioavailability increase of about 26% is associated with mild renal impairment, an average bioavailability increase of about 57% is associated with moderate renal impairment and an average bioavailability increase of about 65% is associated with severe renal impairment. 
     
     
         23 . The method of  claim 21  wherein the information is provided at least via a label associated with the extended release oral dosage form of oxymorphone. 
     
     
         24 . The method of  claim 21  wherein the information further contains a recommendation that subjects with renal impairment be initially administered the lowest available dose of the extended release oral dosage form of oxymorphone or its salt. 
     
     
         25 . A method of providing extended pain relief to a patient in need thereof, comprising:
 reviewing information that the average bioavailability of oxymorphone in an oral extended release formulation designed to have a 12 hour dosing cycle is increased by at least about 26% for subjects with renal impairment compared to that for healthy subjects, and   prescribing a therapeutically effective amount of such an extended release oral dosage form of oxymorphone or its pharmaceutically acceptable salt thereof for said patient.   
     
     
         26 . The method of  claim 25  wherein in the reviewed information an average bioavailability increase of about 26% is associated with mild renal impairment, an average bioavailability increase of about 57% is associated with moderate renal impairment and an average bioavailability increase of about 65% is associated with severe renal impairment. 
     
     
         27 . The method of  claim 25  wherein the reviewed information is provided at least via a label associated with the extended release oral dosage form of oxymorphone. 
     
     
         28 . The method of  claim 25  wherein the reviewed information further contains a recommendation that patients with renal impairment be initially administered the lowest available dose of the extended release oral dosage form of oxymorphone. 
     
     
         29 . The method of  claim 25  wherein the patient for whom the prescription is being written suffers from renal impairment. 
     
     
         30 . A method of providing extended pain relief to patients in need thereof, comprising:
 packaging an oral extended release formulation of oxymorphone or its pharmaceutically acceptable salt thereof with directions that it be administered every 12 hours and with information that the average bioavailability of oxymorphone in an extended release formulation designed to have a 12 hour dosing cycle is increased by at least about 26% for subjects with renal impairment compared to that for healthy subjects and   providing a therapeutically effective amount of said packaged extended release formulation of oxymorphone or its salt to said patient.   
     
     
         31 . The method of  claim 30  wherein in the provided information an average bioavailability increase of about 26% is associated with mild renal impairment, an average bioavailability increase of about 57% is associated with moderate renal impairment and an average bioavailability increase of about 65% is associated with severe renal impairment. 
     
     
         32 . The method of  claim 29  wherein the packaged information is provided at least via a label associated with the packaged extended release formulation of oxymorphone. 
     
     
         33 . The method of  claim 30  wherein the directions further contain a recommendation that patients with renal impairment be initially administered the lowest available dose of the packaged extended release formulation of oxymorphone.