IP Library Granted Patent US 7,659,254
Granted Patent B2
US 7,659,254 · App. 12/201,586 · Granted Feb 9, 2010

Abuse-resistant amphetamine prodrugs

Assignee: Shire LLC
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Quick Facts
Patent No.
US 7,659,254
App. No.
12/201,586
Granted
Feb 9, 2010
Kind
B2
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 (8)

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 MAX of said L-lysine-d-amphetamine or a pharmaceutically acceptable salt thereof in said subject relative to said T 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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2020
From: SHIRE LLC
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 054626/0595 →
Continuity (16)
Continuation 1140030400 · Apr 10, 2006
Continuation In Part 1085761900 · Jun 1, 2004
Continuation In Part 1085852600 · Jun 1, 2004
Continuation In Part PCTUS030552500 · Feb 24, 2003
Provisional Application 6047392900 · May 29, 2003
Provisional Application 6056780100 · May 5, 2004
Provisional Application 6035836800 · Feb 22, 2002
Provisional Application 6036208200 · Mar 7, 2002
Provisional Application 6047392900 · May 29, 2003
Provisional Application 6056780100 · May 5, 2004
Provisional Application 6066938500 · Apr 8, 2005
Provisional Application 6066938600 · Apr 8, 2005
Provisional Application 6068117000 · May 16, 2005
Provisional Application 6075654800 · Jan 6, 2006
Provisional Application 6075995800 · Jan 19, 2006
Related Publication 20090131533A1 · May 21, 2009