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Claims for Patent: 7,919,499

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Claims for Patent: 7,919,499

Title:Naltrexone long acting formulations and methods of use
Abstract: The inventions described herein arose from unexpected discoveries made during clinical trials with a long acting formulation of naltrexone. As such, the invention includes a method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising naltrexone and to the use of naltrexone in the manufacture of medicaments for use in such methods.
Inventor(s): Ehrich; Elliot (Lincoln, MA)
Assignee: Alkermes, Inc. (Waltham, MA)
Application Number:11/083,167
Patent Claims: 1. A method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising about 310 mg to about 480 mg of naltrexone and a biocompatible polymer to the individual wherein the serum AUC of naltrexone is about three times greater than that achieved by 50 mg/day oral administration and wherein the biocompatible polymer is a polylactide-co-glycolide polymer.

2. The method of claim 1 comprising administering the long acting formulation comprising naltrexone every four weeks for a period of about 24 weeks or more wherein the individual has not used oral naltrexone within five or more days before said administration.

3. The method of claim 1 wherein the long acting formulation releases naltrexone for a period of at least two weeks.

4. The method of claim 1 wherein the long acting formulation releases naltrexone for a period of about four weeks.

5. The method of claim 1 wherein the long acting formulation is administered in a dose of about 380 mg of naltrexone wherein the serum AUC is about 3.3 times greater than that achieved by 50 mg/day oral administration.

6. The method of claim 1 wherein the long acting formulation is administered over a period of about 24 week period or longer.

7. The method of claim 1 further comprising a second administration of a long acting formulation comprising naltrexone at least about 7 days after the first administration.

8. The method of claim 7 wherein the second long acting formulation is substantially similar to the first long acting formulation.

9. The method of claim 7 wherein the second long acting formulation is the same as the first long acting formulation.

10. The method of claim 1 wherein the individual is an individual afflicted by alcohol dependency.

11. The method of claim 1 wherein the individual does not receive an initial oral dose of naltrexone.

12. The method of claim 1 wherein naltrexone is administered by injection.

13. The method of claim 1 wherein the naltrexone is present in the long acting formulation at a concentration of about 35% by weight.

14. A method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising about 190 mg to about 240 mg of naltrexone and a biocompatible polymer to the individual wherein the serum AUC of naltrexone is about two times greater than that achieved by 50 mg/day oral administration and wherein the biocompatible polymer is a polylactide-co-glycolide polymer.

15. The method of claim 14 wherein the long acting formulation is administered in a dose of about 190 mg of naltrexone.
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