Use of Oxycodone for Treating Visceral Pain

Abstract

It is possible to effectively treat moderate to severe visceral pain by administering analgesic medications comprising the opioid oxycodone or pharmaceutically acceptable salts thereof. Visceral pain and especially acute (i.e. non-chronic) visceral pain can be effectively treated by administering oxycodone at a dosage which is lower than the corresponding dosage of other opioids like morphine.

1 - 20 . (canceled) 
     
     
         21 . A method of treating visceral pain in a patient, which method comprises the administration of an effective amount of oxycodone or a pharmaceutically acceptable salt thereof. 
     
     
         22 . Method according to  claim 21 , for the treatment of acute visceral pain. 
     
     
         23 . Method according to  claim 21 , for the selective treatment of visceral pain. 
     
     
         24 . Method according to  claim 21 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is contained in an oral dosage form. 
     
     
         25 . Method according to  claim 21 , for the treatment of pancreatitis pain, labor pain, pain from abdominal surgery associated with ileus, pain in irritable bowel syndrome, abdominal pain in nonulcer dyspepsia or in dysmenorrhea, liver pain, kidney pain, epigastric pain pleural pain, painful biliary colic or appendicitis pain. 
     
     
         26 . Method according to  claim 21 , wherein the visceral pain results from diseases of the stomach, dudenum or colon, from Crohn's disease, from pain of the gall bladder, severe menstruational pain, or corresponding post operative pain conditions. 
     
     
         27 . Method according to  claim 21 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is contained in a once-a-day, twice-a-day, three-times-a-day, or four-times-a-day dosage form. 
     
     
         28 . Method according to  claim 21 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is contained in a twice-a-day dosage form at an amount of about 5 mg. 
     
     
         29 . Method according to  claim 21 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is contained in a once-a-day dosage form at an amount of about 10 mg. 
     
     
         30 . Method according to  claim 21 , wherein the medicament is a three-times-a-day dosage form containing oxycodone or a pharmaceutically acceptable salt thereof at an amount of about 5 mg. 
     
     
         31 . Method according, to  claim 21 , wherein the medicament is a four-times-a-day dosage form containing oxycodone or a pharmaceutically acceptable salt thereof at an amount of about 5 mg. 
     
     
         32 . Method according to  claim 21 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is contained in a sustained release dosage form containing not more than 40 mg oxycodone or a pharmaceutically acceptable salt thereof, preferably not more than 30 mg oxycodone or a pharmaceutically acceptable salt thereof and even more preferably not more than 10 mg oxycodone or pharmaceutically acceptable salt thereof. 
     
     
         33 . Method according to  claim 21 , wherein the medicament is a single-entity formulation. 
     
     
         34 . Method according  claim 21 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is contained in an oral dosage form containing oxycodone or a pharmaceutically acceptable salt thereof at a dosage which is lower than the corresponding dosage of morphine required for providing the same therapeutic effect. 
     
     
         35 . Method according to  claim 21 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is orally administered at a dosage which provides a significantly better effect than the orally equipotent dosage of morphine wherein the equipotency refers to the treatment of cutaneous and muscular pain. 
     
     
         36 . Method according to  claim 21 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is orally administered at a dosage which is lower than the equipotent dosage of oral morphine, wherein the equipotency refers to the treatment of cutaneous and muscular pain. 
     
     
         37 . Method according to  claim 36  wherein the ratio of the dosage of oxycodone to the dosage of morphine is less than 1:2, preferably less than 1:2.5, more preferably less than 1:3 and most preferably less than 1:4. 
     
     
         38 . Method according to claim  2 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is contained in an oral controlled release dosage form to control visceral pain in human patients, the dosage form comprising:
 a) from 5 mg to 80 mg oxycodone or a salt thereof;   b) an effective amount of a controlled release acrylic resin matrix, said acrylic resin matrix being selected so that the formulation provides substantially pH-independent in-vitro dissolution characteristics;   c) a pharmaceutical diluent.   
     
     
         39 . A method of treating moderate to severe visceral pain in a patient already being treated with morphine or a salt thereof, the method comprising:
 (a) discontinuing treatment with morphine; and   (b) administering oxycodone or a salt thereof in an amount of less than 50% by weight of the morphine or salt thereof.   
     
     
         40 . Method according to  claim 39 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is orally administered in amount of less than 45% by weight of the morphine or salt thereof, preferably less than 40% by weight, more preferably less than 35% by weight, even more preferably less than 30% by weight and most preferred 25% by weight of the morphine or salt thereof. 
     
     
         41 . A method of treating moderate to severe visceral pain in a patient already being treated with hydromorphone, oxymorphone, codeine, hydrocodone or salts thereof, the method comprising:
 (a) discontinuing treatment with hydromorphone, oxymorphone, codeine, hydrocodone or salts thereof; and   (b) administering oxycodone or a salt thereof in an amount of less than the equipment weight of the hydromorphone, oxymorphone, codeine, hydrocodone or salts thereof.   
     
     
         42 . A method of treating moderate to severe visceral pain in a patient, the method comprising:
 (a) administering to a human patient a unit dose containing oxycodone or a salt thereof in an amount of 5 mg;   (b) monitoring pharmacodynamic parameters elicited by said unit dose in said human patient and determine whether said pharmacodynamic parameters are appropriate for treatment of said patient on a repeated basis;   (c) titrating the patient adjusting the dose of oxycodone or a salt thereof administered to the patient by administering a unit dose of oxycodone or a salt thereof with a different amount of oxycodone or a salt thereof if it is determined that said pharmacodynamic parameters are not satisfactory or maintaining the dose of oxycodone or a salt thereof in said unit dose at a previously adminstered amount if said pharmacodynamic parameters are deemed appropriate; (d) continuing the step (c) titration by adjusting the dose of oxycodone or a salt thereof until appropriate steady-state pharmacodynamic parameters are achieved in said patient, and   (e) continuing the administration of the dose of oxycodone or a salt thereof until treatment is terminated.   
     
     
         43 . Method according to  claim 42 , wherein the patient is titrated with a unit dose containing oxycodone or a salt thereof in an amount of 5 mg to 10 mg.