Abuse-resistant amphetamine compounds

• US 7,105,486 B2
• Filed: 06/01/2004
• Issued: 09/12/2006
• Est. Priority Date: 02/22/2002
• Status: Expired due to Term

• Current Assignee: Takeda Pharmaceutical Company Limited
• Original Assignee: New River Pharmaceuticals Inc. (Shire plc)
• Inventors: Piccariello, Thomas, Bishop, Barney, Krishnan, Suma, Mickle, Travis, Moncrief, James Scott, Lauderback, Christopher, Oberlender, Rob
• Primary Examiner(s): Campell, Bruce R.
• Assistant Examiner(s): AUDET, MAURY A
• Application Number:
  US10/858,526
• Publication Number:
  US 20050054561A1
• Time in Patent Office: 833 Days
• Field of Search: 514/12
• US Class Current: 514/21.3
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 47/542 Carboxylic acids, e.g. a fatty acid or an amino acid

Abstract

The invention describes compounds, compositions and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.

Claims

1. A method for treating a patient having attention deficit hyperactivity disorder, comprising orally administering to the patient in need thereof a pharmaceutically effective amount of L-lysine-d-amphetamine, or salts thereof.

2. The method of claim 1, wherein said step of orally administering comprises administering a tablet, a capsule, a caplet, an oral solution, or an oral suspension.

3. The method of claim 1, wherein the L-lysine-d-amphetamine is administered in the form of a salt.

5. The method of claim 3, wherein the salt is a hydrochloride salt of L-lysine-d-amphetamine.

6. The method of any one of claims 3–

5, wherein said step of orally administering comprises administering a tablet, a capsule, a caplet, an oral solution, or an oral suspension.

7. The method of claim 1, comprising administering a dosage form containing from about 5 mg to about 500 mg of the L-lysine-d-amphetamine or a salt thereof.

8. The method of claim 7, comprising administering a dosage form containing from about 10 mg to about 250 mg of the L-lysine-d-amphetamine or a salt thereof.

9. The method of claim 6, comprising administering a dosage form containing from about 5 mg to about 500 mg of the L-lysine-d-amphetamine or a salt thereof.

10. The method of claim 6, comprising administering a dosage form containing from about 10 mg to about 250 mg of the L-lysine-d-amphetamine or a salt thereof.

11. The method of claim 6, wherein the L-lysine-d-amphetamine or salt thereof is in an amount sufficient to provide a therapeutically bioequivalent AUC when compared to amphetamine alone, but does not provide a C_max which results in euphoria.

12. The method of claim 7, wherein the dosage form is administered one or more times per 24-hour period.

13. The method of claim 8, wherein the dosage form is administered one or more times per 24-hour period.

14. The method of claim 9, wherein the dosage form is administered one or more times per 24-hour period.

15. The method of claim 10, wherein the dosage form is administered one or more times per 24-hour period.

4. The method of 3, wherein the salt is a mesylate salt of L-lysine-d-amphetamine.