USE OF 5-METHOXY-2-AMINOINDAN ("MEAI") IN METHODS FOR TREATING METABOLIC SYNDROME

1 . A method for treating a metabolic condition in a subject in need thereof, comprising administering to the subject a therapeutically acceptable amount of a pharmaceutical composition comprising 5-methoxy-2-aminoindan or a pharmaceutically acceptable salt thereof, wherein the treatment reduces one or more metabolic syndromes in the subject.

2 . The method according to claim 1 , wherein the 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof is administered as a dose of about 20 to about 520 mg.

3 . The method according to claim 1 , wherein the 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof is administered as a dose of about 0.5 to about 40 mg.

4 . The method according to claim 1 , wherein the 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof is administered as a dose of about 20 to about 100 mg, about 25 to about 90 mg, about 30 to about 80 mg, about 40 to about 70 mg, or about 50 to about 60 mg.

5 . The method according to claim 2 , wherein the dose is administered in a single dose or as more than one divided dose.

6 . The method according to claim 2 , wherein the dose is administered daily in a single dose or as more than one divided dose.

7 . The method according to claim 2 , wherein the 5-methoxy-2-aminoindan or a pharmaceutically acceptable salt thereof is administered twice a day.

8 . The method according to claim 1 , wherein the therapeutically effective amount comprises about 0.0084 to about 0.67 mg/kg body weight/day, about 0.33 to about 8.67 mg/kg body weight/day, about 0.33 to about 1.67 mg/kg body weight/day, about 0.42 to about 1.5 mg/kg body weight/day, about 0, to about 1.33 mg/kg body weight/day, about 0.67 to about 1.17 mg/kg body weight/day, or about 0.83 to about 1.0 mg/kg body weight/day.

9 . The method according to claim 1 , wherein the pharmaceutical composition further comprises at least one pharmaceutically acceptable carrier and/or excipient.

10 . The method according to claim 9 , wherein the pharmaceutical composition is a free-flowing powder, a tablet, a capsule, a lozenge, a liquid, a liquid concentrate, suspension, or a syrup.

11 . The method according to claim 10 , wherein the pharmaceutical composition is a unit dosage form composition.

12 . The method according to claim 11 , wherein an amount of 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof in the unit dosage form is about 20 to about 520 mg, about 0.5 to about 40 mg, about 20 to about 100 mg, about 25 to about 90 mg, about 30 to about 80 mg, about 40 to about 70 mg, or about 50 to about 60 mg.

13 . The method according to claim 12 , wherein the amount of 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof is about 50 mg.

14 . The method according to claim 1 , wherein administration of the pharmaceutical composition is oral, sublingual, buccal, vaginal, rectal, parenteral, transdermal, or by inhalation.

15 . The method of claim 14 , wherein the parenteral administration is intravenous, intramuscular, or subcutaneous.

16 . A method for treating a metabolic condition in a subject in need thereof, comprising administering to the subject a therapeutically acceptable amount of a pharmaceutical composition comprising 5-methoxy-2-aminoindan or a pharmaceutically acceptable salt thereof, and a pharmaceutical composition comprising an N-acylethanolamine or a pharmaceutically acceptable salt thereof, wherein the treatment reduces one or more metabolic syndromes in the subject.

17 . The method according to claim 16 , wherein the 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof is administered as a dose of about 20 to about 520 mg.

18 . The method according to claim 16 , wherein the 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof is administered as a dose of about 0.5 to about 40 mg.

19 . The method according to claim 16 , wherein the 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof is administered as a dose of about 20 to about 100 mg, about 25 to about 90 mg, about 30 to about 80 mg, about 40 to about 70 mg, or about 50 to about 60 mg.

20 . The method according to claim 17 , wherein the dose is administered in a single dose or in more than one divided dose.

21 . The method according to claim 17 , wherein the dose is administered daily in a single dose or in more than one divided dose.

22 . The method according to claim 19 , wherein the 5-methoxy-2-aminoindan or a pharmaceutically acceptable salt thereof is administered twice a day.

23 . The method according to claim 16 , wherein the therapeutically effective amount of the 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof comprises about 0.0084 to about 0.67 mg/kg body weight/day, about 0.33 to about 8.67 mg/kg body weight/day, about 0.33 to about 1.67 mg/kg body weight/day, about 0.42 to about 1.5 mg/kg body weight/day, about 0, to about 1.33 mg/kg body weight/day, about 0.67 to about 1.17 mg/kg body weight/day, or about 0.83 to about 1.0 mg/kg body weight/day.

24 . The method according to claim 16 , wherein the pharmaceutical composition further comprises at least one pharmaceutically acceptable carrier and/or excipient.

25 . The method according to claim 24 , wherein the pharmaceutical composition is a free-flowing powder, a tablet, a capsule, a lozenge, a liquid, a liquid concentrate, suspension, or a syrup.

26 . The method according to claim 25 , wherein the pharmaceutical composition is a unit dosage form composition.

27 . The method according to claim 26 , wherein an amount of 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof in the unit dosage form is about 20 to about 520 mg, about 0.5 to about 40 mg, about 20 to about 100 mg, about 25 to about 90 mg, about 30 to about 80 mg, about 40 to about 70 mg, or about 50 to about 60 mg.

28 . The method according to claim 27 , wherein the amount of 5-methoxy-2-aminoindan or pharmaceutically acceptable salt thereof is about 50 mg.

29 . The method according to claim 16 , wherein administration of the pharmaceutical composition is oral, sublingual, buccal, vaginal, rectal, parenteral, transdermal, or by inhalation.

30 . The method of claim 29 , wherein the parenteral administration is intravenous, intramuscular, or subcutaneous.

31 . The method of any one of claims 16 to 30 , 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.

32 . The method according to claim 31 , wherein the N-acylethanolamine is palmitoylethanolamide or a pharmaceutically acceptable salt thereof.

33 . The method of any one of claims 16 to 32 , wherein the N-acylethanolamine or pharmaceutically acceptable salt thereof is administered as a dose of about 200 to about 1800 mg, about 250 to about 1550 mg, about 300 to about 1200 mg, about 350 to about 950 mg, about 400 to about 700 mg, about 450 to about 600 mg, or about 500 to about 550 mg.

34 . The method according to claim 33 , wherein the dose is administered in a single dose or in more than one divided dose.

35 . The method according to claim 33 , wherein the dose is administered daily in a single dose or in more than one divided dose.

36 . The method according to claim 35 , wherein the N-acylethanolamine or a pharmaceutically acceptable salt thereof is administered twice a day.

37 . The method according to claim 16 , wherein the therapeutically effective amount of the N-acylethanolamine or pharmaceutically acceptable salt thereof comprises about 2.5 to about 36.0 mg/kg body weight/day, about 3.12 to about 31.0 mg/kg body weight/day, about 3.75 to about 24.0 mg/kg body weight/day, about 4.38 to about 19.0 mg/kg body weight/day, about 5.0 to about 14.0 mg/kg body weight/day, about 5.62 to about 12.0 mg/kg body weight/day, or about 6.25 to about 11.0 mg/kg body weight/day.

38 . The method of any one of claims 16 to 37 , wherein the N-acylethanolamine is administered simultaneously with the 5-methoxy-2-aminoindan.

39 . The method of claim 38 , wherein the N-acylethanolamine and the 5-methoxy-2-aminoindan are administered in a single pharmaceutical composition.

40 . The method of claim 1 or 16 , wherein administration is oral, mucosal, nasal, sublingual, inhalational, topical, rectal, vaginal, or parenteral route.

41 . The method of claim 40 , wherein the parenteral administration is intravenous, intramuscular, or subcutaneous.

42 . The method of any one of claims 1 to 41 , wherein treating metabolic syndrome involves one or more of decreasing blood pressure, decreasing blood sugar, reducing body fat around the waist, normalizing abnormal cholesterol or triglyceride levels, reducing obesity, reducing overweight, reducing body weight, increasing lean mass, reducing fat mass, reducing adiposity, increasing energy expenditure, improving glycemic control, decreasing hepatic steatosis, decreasing sugar intake, decreasing food intake, maintaining glucose homeostasis, lowering dyslipidemia, or preserving liver function.

43 . The method of claim 42 , wherein improving glycemic control involves one or more of improving glucose metabolism, reducing fasting blood glucose level, or reducing insulin level.

44 . The method of claim 42 , wherein increasing energy expenditure involves one or more of increasing oxygen consumption and carbon dioxide emission, increasing fat oxidation, or increasing locomotive activity.

45 . The method of claim 42 , wherein treating metabolic syndrome reduces obesity.

46 . The method of claim 45 , wherein treating metabolic syndrome involves reducing overweight associated with obesity.

47 . The method of claim 45 or 46 , wherein treating metabolic syndrome preserves lean mass of the subject.

48 . The method of claim 45 or 46 , wherein treating metabolic syndrome decreases fat mass of the subject.

49 . The method of claim 45 or 46 , wherein treating metabolic syndrome reduces adiposity of the subject.

50 . The method of claim 45 or claim 46 , wherein treating metabolic syndrome increases energy expenditure.

51 . The method of claim 50 , wherein food consumption is unchanged.

52 . The method of claim 59 , wherein fat utilization is increased.

53 . The method of claim 50 , wherein locomotive activity is normalized without over-stimulatory effects.

54 . The method of claim 45 or claim 46 , wherein treating metabolic syndrome improves glycemic control.

55 . The method of claim 45 or claim 46 , wherein treating metabolic syndrome reverses hyperglycemia, glucose intolerance, or hyperinsulinemia.

56 . The method of claim 45 or claim 46 , wherein treating metabolic syndrome improves hepatic steatosis.

57 . The method of claim 56 , wherein improving hepatic steatosis involves one or more of reducing hepatic lipid accumulation, hepatic triglyceride levels, or hepatic cholesterol levels.

58 . The method of claim 45 or claim 46 , wherein treating metabolic syndrome preserves glucose homeostasis.

59 . The method of claim 58 , wherein preserving glucose homeostasis involves one or more of enhancing glucose tolerance, attenuating insulin resistance, reducing dyslipidemia, or reducing hepatic lipid accumulation.

60 . Use of a pharmaceutical composition comprising 5-methoxy-2-aminoindan or a pharmaceutically acceptable salt thereof for treating a metabolic condition as in any one of claims 1-59 .

61 . Use of a pharmaceutical composition comprising 5-methoxy-2-aminoindan or a pharmaceutically acceptable salt thereof, and an N-acylethanolamine (e.g., palmitoylethanolamide) or a pharmaceutically acceptable salt thereof, for treating a metabolic condition as in any one of claims 16-59 .