Methods for acute and long-term treatment of drug addiction

Patent metadata

Field	Value
Publication number	US-9345711-B2
Application number	US-201414195822-A
Country	US
Kind code	B2
Filing date	Mar 3, 2014
Priority date	Feb 18, 2014
Publication date	May 24, 2016
Grant date	May 24, 2016

Abstract

This invention is directed to a method of treating opioid or opioid-like drug addiction, including acute and post-acute withdrawal symptoms, comprising treating an addicted patient with noribogaine at a dosage that provides an average serum concentration of about 50 ng/mL to about 850 ng/mL (AUC/24 h) under conditions where the QT interval prolongation does not exceed about 50 milliseconds.

First claim

What is claimed is:

1. A method for treating opioid or opioid-like drug abuse in a human patient addicted thereto, comprising administering to the patient an aggregate dosage of noribogaine or pharmaceutically acceptable salt or solvate thereof that provides an average serum concentration of about 50 ng/mL to about 500 ng/mL, said concentration being sufficient to inhibit or ameliorate said abuse while targeting a maximum QT interval prolongation of less than about 40 milliseconds during said treatment, wherein the aggregate dosage of noribogaine or pharmaceutically acceptable salt or solvate thereof is from about 60 mg to about 120 mg per day.

2. The method of claim 1 , wherein the aggregate dosage of noribogaine or pharmaceutically acceptable salt or solvate thereof is administered as a single dose or multiple doses.

3. The method of claim 1 , wherein the aggregate dosage of noribogaine or pharmaceutically acceptable salt or solvate thereof is about 120 mg per day.

4. The method of claim 1 , wherein the aggregate dosage of noribogaine or pharmaceutically acceptable salt or solvate thereof provides an average serum concentration of about 50 ng/mL to about 200 ng/mL.

5. The method of claim 1 , wherein the QT interval prolongation provides for a QT interval to be maintained at less than about 470 milliseconds during said treatment.

6. The method of claim 5 , wherein the patient's QT interval is maintained at less than about 450 milliseconds during said treatment.

7. The method of claim 1 , further comprising selecting an addicted patient who is prescreened to evaluate tolerance for prolongation of QT interval.

8. The method of claim 7 , wherein the prescreening step comprises ascertaining that noribogaine treatment will not result in a QT interval greater than about 500 milliseconds.

9. The method of claim 8 , wherein the prescreening step comprises ascertaining that noribogaine treatment will not result in a QT interval greater than about 470 milliseconds.

10. The method of claim 8 , wherein the prescreening step comprises ascertaining that noribogaine treatment will not result in a QT interval greater than about 450 milliseconds.

11. A method for attenuating withdrawal symptoms in a human patient susceptible to such symptoms due to opioid or opioid-like drug addiction, comprising administering to the patient an aggregate dosage of noribogaine or pharmaceutically acceptable salt or solvate thereof that provides an average serum concentration of about 50 ng/mL to about 400 ng/mL, said concentration being sufficient to attenuate said symptoms while targeting a maximum QT interval prolongation of less than about 40 milliseconds during said treatment, wherein the aggregate dosage of noribogaine or pharmaceutically acceptable salt or solvate thereof is from about 60 mg to about 120 mg per day.

12. The method of claim 11 , wherein the withdrawal symptoms are due to acute withdrawal.

13. The method of claim 11 , wherein the aggregate dosage of noribogaine or pharmaceutically acceptable salt or solvate thereof is administered as a single dose or multiple doses.

14. The method of claim 11 , wherein the aggregate dosage of noribogaine or pharmaceutically acceptable salt or solvate thereof is about 120 mg per day.

15. The method of claim 11 , wherein the QT interval prolongation provides for a QT interval to be maintained at less than about 470 milliseconds during said treatment.

16. The method of claim 15 , wherein the patient's QT interval is maintained at less than about 450 milliseconds during said treatment.

Assignees

• Demerx Inc

Inventors

• Friedhoff Lawrence

Classifications

• A61K31/407

  condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine · CPC title

• A61K31/55 Primary

  having seven-membered rings, e.g. azelastine, pentylenetetrazole · CPC title