COMPOSITIONS COMPRISING PSILOCYBIN, OPTIONALLY IN COMBINATION WITH N-ACYLETHANOLAMINES AND USES THEREOF
The present disclosure relates to pharmaceutical compositions comprising psilocybin, or a pharmaceutically acceptable salt thereof, and combinations of psilocybin, or a pharmaceutically acceptable salt thereof and an N-acylethanolamine, or a pharmaceutically salt thereof, and at least one pharmaceutically acceptable carrier and/or excipient, and their use in methods of treating alcohol or substance dependence, tobacco, alcohol or substance addiction, mood disorders, personality disorders, neuropsychiatric disorders, headaches, pain, epilepsy, and inflammation, by administrating said compositions to a subject in need thereof in a therapeutically effective amount.
1 . A pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier and/or excipient.
2 . The pharmaceutical composition of claim 1 , wherein the composition is a unit dosage from composition.
3 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition is a solid unit dosage form composition.
4 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition is a liquid unit dosage form composition.
5 . The pharmaceutical composition of claim 2 , wherein the pharmaceutical composition is packaged as a single unit dose or as a plurality of single unit doses.
6 . The pharmaceutical composition of claim 2 , wherein the unit dosage form comprises from 1-50 mg of psilocybin or a pharmaceutically acceptable salt thereof.
7 . The pharmaceutical composition of claim 2 , wherein the unit dosage form comprises from about 10 mg/70 kg to 50 mg/70 kg body weight of psilocybin or a pharmaceutically acceptable salt thereof.
8 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for oral administration, sublingual administration, or intravenous administration.
9 . A method of treating substance dependence or addiction, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin or a pharmaceutically acceptable salt thereof.
10 . A method of treating anxiety disorders, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof.
11 . A method of treating depression or depression-like disorders, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof.
12 . A method of treating personality disorders, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof.
13 . A method of treating pain or headaches, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof.
14 . A method of treating epilepsy, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof.
15 . A method of treating inflammation, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof.
16 . The method of claim 9, 10, 11, 12, 13, 14, or 15 , wherein the pharmaceutical composition further comprises at least on pharmaceutically acceptable carrier and/or excipient.
17 . The method of claim 9, 10, 11, 12, 13, 14, or 15 , wherein the pharmaceutical composition is a free-flowing powder, a tablet, a capsule, a lozenge, a liquid, a liquid concentrate, or a syrup.
18 . The method of claim 9, 10, or 11 , wherein the pharmaceutical composition is a unit dosage form composition.
19 . The method of claim 9, 10, or 11 , wherein an amount of psilocybin or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 1-50 mg.
20 . The method of claim 9, 10, or 11 , wherein an amount of psilocybin or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 10 mg/70 kg to 50 mg/70 kg body weight.
21 . A pharmaceutical composition comprising psilocybin or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier and/or excipient.
22 . The pharmaceutical composition of claim 21 , wherein the composition is a unit dosage from composition.
23 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition is a solid unit dosage form composition.
24 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition is a liquid unit dosage form composition.
25 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition is packaged as a single unit dose or as a plurality of single unit doses.
26 . The pharmaceutical composition of claim 22 , wherein the unit dosage form comprises from 1-50 mg of psilocybin or a pharmaceutically acceptable salt thereof.
27 . The pharmaceutical composition of claim 22 , wherein the unit dosage form comprises from about 10 mg/70 kg to 50 mg/70 kg body weight of psilocybin or a pharmaceutically acceptable salt thereof.
28 . The pharmaceutical composition of claim 22 , wherein the unit dosage form comprises from 50 mg to 1800 mg of N-acylethanolamine or a pharmaceutically acceptable salt thereof.
29 . The pharmaceutical composition of claim 21 , wherein the pharmaceutical composition is formulated for oral administration or intravenous administration.
30 . A method of treating substance dependence or addiction, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
31 . A method of treating anxiety disorders, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
32 . A method of treating depression or depression-like disorders, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
33 . A method of treating personality disorders, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
34 . A method of treating pain or headaches, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
35 . A method of treating epilepsy, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
36 . A method of treating inflammation, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising psilocybin, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
37 . The method of claim 30, 31, 32, 33, 34, 35, or 36 , wherein the pharmaceutical composition further comprises at least on pharmaceutically acceptable carrier and/or excipient.
38 . The method of claim 30, 31, 32, 33, 34, 35, or 36 , wherein the pharmaceutical composition is a unit dosage form composition.
39 . The method of claim 30, 31, 32, 33, 34, 35, or 36 , wherein an amount of psilocybin or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 1-50 mg.
40 . The method of claim 30, 31, 32, 33, 34, 35, or 36 , wherein an amount of psilocybin or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 10 mg/70 kg to 50 mg/70 kg body weight.
41 . The pharmaceutical composition of any preceding claim , wherein the N-acylethanolamine is selected from the group consisting of N-palmitoylethanolamine (PEA), Me-palmitoylethanolamide (Me-PEA), palmitoylcyclohexamide, palmitoylbutylamide, palmitoylisopropylamide, oleoylethanolamine (OEA), palmitoylisopropylamide (PIA), salts thereof and any combination thereof.
42 . The method of any preceding claim , wherein the N-acylethanolamine is selected from the group consisting of N-palmitoylethanolamine (PEA), Me-palmitoylethanolamide (Me-PEA), palmitoylcyclohexamide, palmitoylbutylamide, palmitoylisopropylamide, oleoylethanolamine (OEA), palmitoylisopropylamide (PIA), salts thereof and any combination thereof.
43 . The pharmaceutical composition of any preceding claim , wherein the N-acylethanolamine is PEA or a pharmaceutically acceptable salt thereof.
44 . The method of any preceding claim , wherein the N-acylethanolamine is PEA or a pharmaceutically acceptable salt thereof.