Methods and compositions for reducing the risk associated with the administration of opioid analgesics in patients diagnosed or undiagnosed respiratory illness

Abstract

The present invention relates to methods for reducing the risk associated with the administration of opioid analgesics in patient diagnosed or undiagnosed with respiratory illness by administering an analgesic composition comprising a sub-analgesic dosage of a p-opioid agonist selected from the group consisting a morphine, fentanyl, sufentanil, alfentanil, oxymorphone and hydromorphone, or a pharmaceutically acceptable salt thereof, and a sub-analgesic dosage of oxycodone which is a κ2-opioid agonist or a pharmaceutically acceptable salt thereof.

1 - 4 . (canceled) 
     
     
         5 . A composition for treating a human in need thereof for the alleviation or prevention of pain, said composition comprising:
 (i) an oral human sub-analgesic dose of a pharmaceutically acceptable salt of morphine, wherein the pharmaceutically acceptable salt is a sulphate salt or a hydrochloride salt; and   (ii) an oral human sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone, wherein the pharmaceutically acceptable salt is a hydrochloride salt;   wherein the pharmaceutically acceptable salt of morphine and the pharmaceutically acceptable salt of oxycodone are in a ratio of about 1:0.66 by weight, and wherein the composition is suitable for oral administration to humans.   
     
     
         6 . The composition of  claim 5 , wherein the pharmaceutically acceptable salt of morphine is the sulphate salt. 
     
     
         7 . The composition of  claim 5 , wherein the composition is in the form of a capsule or tablet. 
     
     
         8 . The composition of  claim 7 , wherein the composition is in the form of a capsule. 
     
     
         9 . The composition of  claim 5 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 3 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity of about 2 mg. 
     
     
         10 . The composition of  claim 5 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 6 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity of about 4 mg. 
     
     
         11 . The composition of  claim 5 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 9 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity of about 6 mg. 
     
     
         12 . The composition of  claim 5 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 12 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity of about 8 mg. 
     
     
         13 . The composition of  claim 5 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 15 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity of about 10 mg. 
     
     
         14 . The composition of  claim 5 , wherein the composition is in an immediate release, sustained release, or controlled-release dosage form. 
     
     
         15 . The composition of  claim 14 , wherein the composition is in an immediate release dosage form. 
     
     
         16 . A composition for treating a human in need thereof for the alleviation or prevention of pain, said composition comprising:
 (i) an oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine, wherein the pharmaceutically acceptable salt is a sulphate salt; and   (ii) an oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone, wherein the pharmaceutically acceptable salt is a hydrochloride salt;   wherein the pharmaceutically acceptable salt of morphine and the pharmaceutically acceptable salt of oxycodone are in a ratio of about 1:0.66 by weight, and wherein the composition is in an immediate release capsule dosage form and is suitable for oral administration to humans.   
     
     
         17 . The composition of  claim 16 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 3 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity about 2 mg. 
     
     
         18 . The composition of  claim 16 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 6 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity of about 4 mg. 
     
     
         19 . The composition of  claim 16 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 9 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity of about 6 mg. 
     
     
         20 . The composition of  claim 16 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 12 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity of about 8 mg. 
     
     
         21 . The composition of  claim 16 , wherein the oral sub-analgesic dose of a pharmaceutically acceptable salt of morphine is in a quantity of about 15 mg; and the oral sub-analgesic dose of a pharmaceutically acceptable salt of oxycodone is in a quantity of about 10 mg.