COMBINATIONS OF OPIOIDS AND N-ACYLETHANOLAMINES
The present invention provides pharmaceutical compositions comprising opioids and N-acylethanolamines, and methods for their use in preventing and treating a variety of opioid-responsive conditions and opioid-related side-effects.
1 .- 34 . (canceled)
35 . A method for preventing or treating at least one side-effect associated with opioid consumption in a human subject in need thereof, comprising administering to the subject a therapeutically-effective amount of a pharmaceutical composition comprising at least one opioid or a salt thereof, and at least one N-acylethanolamine or a salt thereof, in a molar ratio of the opioid and N-acylethanolamine between about 1:1 to about 1:100, thereby preventing or treating the at least one side-effect.
36 . The method of claim 35 , wherein the molar ratio between the at least one opioid or a salt thereof, and the at least one N-acylethanolamine or a salt thereof is between about 1:2 to about 1:80.
37 . The method of claim 35 , wherein the molar ratio between the at least one opioid or a salt thereof, and the at least one N-acylethanolamine or a salt thereof is between about 1:2.5 to about 1:5.
38 . The method of claim 35 , wherein the pharmaceutical composition comprises about 1-100 mg of opioid or a salt thereof.
39 . The method of claim 35 , wherein the pharmaceutical composition comprises about 20 mg, about 35 mg, about 55 mg, about 70 mg or about 90 mg of opioid or a salt thereof.
40 . The method of claim 35 , wherein the at least one opioid is oxycodone, morphine, codeine, fentanyl, tramadol, hydrocodone, meperidine, hydromorphone, methadone, naloxone, a salt thereof, or any combination thereof.
41 . The method of claim 40 , wherein the at least one opioid is oxycodone or a salt thereof.
42 . The method of claim 35 , wherein the pharmaceutical composition comprises about 200-1800 mg of N-acylethanolamine or a salt thereof.
43 . The method of claim 42 , wherein the pharmaceutical composition comprises about 250 mg, about 500 mg, about 750 mg, about 1000 mg or about 1500 mg of N-acylethanolamine or a salt thereof.
44 . The method of claim 35 , wherein the at least one N-acylethanolamine is N-palmitoylethanolamine (PEA), Me-palmitoylethanolamide (Me-PEA), palmitoylcyclohexamide, palmitoylbutylamide, palmitoylisopropylamide, oleoylethanolamine (OEA), palmitoylisopropylamide (PIA), a salt thereof, or any combination thereof.
45 . The method of claim 44 , wherein the N-acylethanolamine is PEA or a salt thereof.
46 . The method of claim 35 , wherein the pharmaceutical composition comprises oxycodone or a salt thereof, and PEA or a salt thereof.
47 . The method of claim 46 , wherein the pharmaceutical composition comprises about 1-100 mg of oxycodone or a salt thereof, and about 200-1800 mg of PEA or a salt thereof.
48 . The method of claim 47 , wherein the pharmaceutical composition comprises about 20 mg, about 35 mg, about 55 mg, about 70 mg, about 90 mg of oxycodone or a salt thereof, and about 250 mg, about 500 mg, about 750 mg, about 1000 mg or about 1500 mg of PEA or a salt thereof.
49 . The method of claim 35 , wherein the pharmaceutical composition is formulated for systemic administration.
50 . The method of claim 49 , wherein the pharmaceutical composition is formulated for oral, oral mucosal, nasal, sublingual, inhalational, topical, rectal, vaginal, parenteral, intravenous, intramuscular, or subcutaneous administration.
51 . The method of claim 50 , wherein the pharmaceutical composition is formulated for oral, oral mucosal, nasal, or sublingual administration.
52 . The method of claim 35 , wherein the administration of the opioid and the N-acylethanolamine is repeated.
53 . The method of claim 35 , wherein the side-effect associated with opioid consumption is irritation.
54 . The method of claim 35 , wherein the side-effect associated with opioid consumption is confusion, uncontrolled movement, or disorientation.