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Claims for Patent: 7,659,254

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Claims for Patent: 7,659,254

Title:Abuse-resistant amphetamine prodrugs
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.
Inventor(s): Mickle; Travis (Coralville, IA), Krishnan; Suma (Belvedere, CA), Bishop; Barney (Annandale, VA), Lauderback; Christopher (Blacksburg, VA), Moncrief; James Scott (Christiansburg, VA), Oberlender; Robert (Blacksburg, VA), Piccariello; Thomas (Blacksburg, VA), Paul; Bernhard J. (Lexington, MA), Verbicky; Christopher A. (Broadalbin, NY)
Assignee: Shire LLC (Florence, KY)
Application Number:12/201,586
Patent Claims: 1. A method of treating an adult subject having attention deficit hyperactivity disorder, said method comprising orally administering to said subject a pharmaceutically effective amount of L-lysine-d-amphetamine or a pharmaceutically acceptable salt thereof.

2. A method of treating an adult subject having attention deficit hyperactivity disorder, said method comprising orally administering to said subject a pharmaceutically effective amount of L-lysine-d-amphetamine or a pharmaceutically acceptable salt thereof with intake of food by said subject.

3. A method as defined in claim 2, wherein said subject is administered a mesylate salt of L-lysine-d-amphetamine.

4. A method as defined in claim 3, wherein said subject is administered L-lysine-d-amphetamine dimesylate.

5. A method as defined in claim 2, wherein said subject is administered 30 mg of L-lysine-d-amphetamine or a pharmaceutically acceptable salt thereof once daily.

6. A method as defined in claim 2, wherein said subject is administered 50 mg of L-lysine-d-amphetamine or a pharmaceutically acceptable salt thereof once daily.

7. A method as defined in claim 2, wherein said subject is administered 70 mg of L-lysine-d-amphetamine or a pharmaceutically acceptable salt thereof once daily.

8. A method as defined in claim 2, wherein said administration is of a pharmaceutically effective amount that results in a delay by approximately one hour of the T.sub.MAX of said L-lysine-d-amphetamine or a pharmaceutically acceptable salt thereof in said subject relative to said T.sub.MAX in an adult patient administered said pharmaceutically effective amount of L-lysine-d-amphetamine or a pharmaceutically acceptable salt thereof in the absence of food.
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