COMPOSITIONS COMPRISING ENZYME-CLEAVABLE AMPHETAMINE PRODRUGS AND INHIBITORS THEREOF
The embodiments provide Compound AM-9, Amphetamine-arginine-glycine-acetate, or acceptable salts, solvates, and hydrates thereof and Compound AM-10, Amphetamine-arginine-alanine-acetate. The present disclosure also provides compositions, and their methods of use, where the compositions comprise a prodrug, Compound AM-9 or Compound AM-10, that provides controlled release of amphetamine Such compositions can optionally provide a trypsin inhibitor that interacts with the enzyme that mediates the controlled release of amphetamine from the prodrug so as to attenuate enzymatic cleavage of the prodrug.
1 . Amphetamine-arginine-glycine-acetate, Compound AM-9, shown below:
or acceptable salts, solvates, and hydrates thereof.
2 . A composition comprising amphetamine-arginine-glycine-acetate, Compound AM-9, shown below:
or acceptable salts, solvates, and hydrates thereof.
3 . A method of treating or preventing pain in a patient in need thereof, which comprises administering an effective amount of a compound of claim 1 or a composition of claim 2 to the patient.
4 . A compound of claim 1 for use in medical therapy.
5 . A compound of claim 1 for use in the treatment or prevention of attention deficit hyperactivity disorder (ADHD).
6 . A composition comprising a trypsin inhibitor and amphetamine-arginine-glycine-acetate, Compound AM-9, shown below:
or acceptable salts, solvates, and hydrates thereof.
7 . Use of the compound of claim 1 or a composition of any one of claims 2 and 6 in the manufacture of a medicament for treatment or prevention of attention deficit hyperactivity disorder (ADHD).
8 . Amphetamine-arginine-alanine-acetate, Compound AM-10, shown below:
or acceptable salts, solvates, and hydrates thereof.
9 . A composition comprising amphetamine-arginine-alanine-acetate, Compound AM-10, shown below:
or acceptable salts, solvates, and hydrates thereof.
10 . A method of treating or preventing pain in a patient in need thereof, which comprises administering an effective amount of a compound of claim 8 or a composition of claim 9 to the patient.
11 . A compound of claim 8 for use in medical therapy.
12 . A compound of claim 8 for use in the treatment or prevention of attention deficit hyperactivity disorder (ADHD).
13 . A composition comprising a trypsin inhibitor and amphetamine-arginine-alanine-acetate, Compound AM-10, shown below:
or acceptable salts, solvates, and hydrates thereof.
14 . Use of the compound of claim 8 or a composition of any one of claims 9 and 13 in the manufacture of a medicament for treatment or prevention of attention deficit hyperactivity disorder (ADHD).
15 . A method of treating or preventing attention deficit hyperactivity disorder (ADHD) in a patient in need thereof, which comprises administering an effective amount of a compound of any one of claims 1 and 8 or a composition of any one of claims 2 , 6 , 9 and 13 to the patient.