COMPOSITIONS COMPRISING 3,4-METHYLENEDIOXYMETHAMPHETAMINE, OPTIONALLY IN COMBINATION WITH N-ACYLETHANOLAMINES, AND USES THEREOF
The present disclosure relates to pharmaceutical compositions comprising 3,4-methylenedioxymethamphetamine (MDMA), or a salt thereof, and combinations of MDMA, or pharmaceutically acceptable salts thereof and N-acylethanolamines, or pharmaceutically acceptable salts thereof, for example, palmitoylethanolamide (“PEA”), and at least one pharmaceutically acceptable carrier and/or excipient, and their use in methods of treating post-traumatic stress disorder (PTSD), anxiety, and eating disorders by administrating said compositions to a subject in need thereof in a therapeutically effective amount.
1 . A pharmaceutical composition comprising 3,4-methylenedioxymethamphetamine, 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 50-200 mg of 3,4-methylenedioxymethamphetamine or a pharmaceutically acceptable salt thereof.
7 . The pharmaceutical composition of claim 2 , wherein the unit dosage form comprises from 0.2 mg/kg to 5 mg/kg body weight of 3,4-methylenedioxymethamphetamine 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 post-traumatic stress disorder, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising 3,4-methylenedioxymethamphetamine, or a pharmaceutically acceptable salt thereof.
10 . A method of treating anxiety, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising 3,4-methylenedioxymethamphetamine, or a pharmaceutically acceptable salt thereof.
11 . A method of treating eating disorders, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising 3,4-methylenedioxymethamphetamine, or a pharmaceutically acceptable salt thereof.
12 . The method of claim 9, 10, or 11 , wherein the pharmaceutical composition further comprises at least on pharmaceutically acceptable carrier and/or excipient.
13 . The method of claim 9, 10, or 11 , wherein the pharmaceutical composition is a free-flowing powder, a tablet, a capsule, a lozenge, a liquid, a liquid concentrate, or a syrup.
14 . The method of claim 9, 10, or 11 , wherein the pharmaceutical composition is a unit dosage form composition.
15 . The method of claim 9, 10, or 11 , wherein an amount of 3,4-methylenedioxymethamphetamine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 50-200 mg.
16 . The method of claim 9, 10, or 11 , wherein an amount of 3,4-methylenedioxymethamphetamine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 0.2 mg/kg to 5 mg/kg body weight.
17 . The method of claim 9, 10, or 11 , wherein the pharmaceutical composition is administered orally or intravenously.
18 . A pharmaceutical composition comprising 3,4-methylenedioxymethamphetamine 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.
19 . The pharmaceutical composition of claim 18 , wherein the composition is a unit dosage from composition.
20 . The pharmaceutical composition of claim 19 , wherein the pharmaceutical composition is a solid unit dosage form composition.
21 . The pharmaceutical composition of claim 19 , wherein the pharmaceutical composition is a liquid unit dosage form composition.
22 . The pharmaceutical composition of claim 19 , wherein the pharmaceutical composition is packaged as a single unit dose or as a plurality of single unit doses.
23 . The pharmaceutical composition of claim 19 , wherein the unit dosage form comprises from 50-200 mg of 3,4-methylenedioxymethamphetamine or a pharmaceutically acceptable salt thereof.
24 . The pharmaceutical composition of claim 19 , wherein the unit dosage form comprises from 0.2 mg/kg to 5 mg/kg body weight of 3,4-methylenedioxymethamphetamine or a pharmaceutically acceptable salt thereof.
25 . The pharmaceutical composition of claim 19 , wherein the unit dosage form comprises from 50 mg to 1800 mg of N-acylethanolamine or a pharmaceutically acceptable salt thereof.
26 . The pharmaceutical composition of claim 18 , wherein the pharmaceutical composition is formulated for oral administration or intravenous administration.
27 . A method of treating post-traumatic stress disorder, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising 3,4-methylenedioxymethamphetamine, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
28 . A method of treating anxiety, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising 3,4-methylenedioxymethamphetamine, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
29 . A method of treating eating disorders, comprising administrating to a subject in need thereof a therapeutically effective amount of a pharmaceutical composition comprising 3,4-methylenedioxymethamphetamine, or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine, or a pharmaceutically acceptable salt thereof.
30 . The method of claim 27, 28, or 29 , wherein the pharmaceutical composition further comprises at least on pharmaceutically acceptable carrier and/or excipient.
31 . The method of claim 27, 28, or 29 , wherein the pharmaceutical composition is a free-flowing powder, a tablet, a capsule, a lozenge, a liquid, a liquid concentrate, or a syrup.
32 . The method of claim 27, 28, or 29 , wherein the pharmaceutical composition is a unit dosage form composition.
33 . The method of claim 27, 28, or 29 , wherein an amount of 3,4-methylenedioxymethamphetamine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 50-200 mg.
34 . The method of claim 27, 28, or 29 , wherein an amount of 3,4-methylenedioxymethamphetamine or a pharmaceutically acceptable salt thereof in the unit dosage form ranges from about 0.2 mg/kg to 5 mg/kg body weight.
35 . The method of claim 27, 28, or 29 , wherein the pharmaceutical composition is administered orally or intravenously.
36 . 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.
37 . 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.
38 . The pharmaceutical composition of any preceding claim , wherein the N-acylethanolamine is PEA or a pharmaceutically acceptable salt thereof.
39 . The method of any preceding claim , wherein the N-acylethanolamine is PEA or a pharmaceutically acceptable salt thereof.