Method for treating nicotine withdrawal

• US 5,696,115 A
• Filed: 04/21/1995
• Issued: 12/09/1997
• Est. Priority Date: 04/21/1995
• Status: Expired due to Fees

• Current Assignee: Eli Lilly and Company
• Original Assignee: Eli Lilly and Company
• Inventors: Rasmussen, Kurt
• Primary Examiner(s): Cintins, Marianne M.
• Assistant Examiner(s): MOEZIE, MINNA FAY
• Application Number:
  US08/422,202
• Time in Patent Office: 963 Days
• Field of Search: 514/220, 514/813
• US Class Current: 514/220
• CPC Class Codes: A61K 31/551 having two nitrogen atoms, e.g. dilazep

Abstract

The invention provides a method for treating a condition resulting from the cessation and withdrawal of nicotine comprising administering an effective amount of 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno 2,3-b! 1,5!-benzodiazepine.

Claims

1. A method for treating a mammal suffering withdrawal from or dependence on nicotine, comprising administering an effective amount of 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno 2,3-b! 1,5!benzodiazepine, or a pharmaceutically acceptable salt thereof, to the mammal.

2. A method of claim 1 wherein the 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno 2,3-b! 1,5!benzodiazepine is substantially pure Form I having a typical X-ray powder diffraction pattern substantially as follows, using a Sieman'"'"'s DS5000 diffractometer wherein d represents the interplanar spacing in Angstroms:

10.2689

8.577

7.4721

7.125

6.1459

6.071

5.4849

5.2181

5.1251

4.9874

4.7665

4.7158

4.4787

4.3307

4.2294

4.141

3.9873

3.7206

3.5645

3.5366

3.3828

3.2516

3.134

3.0848

3.0638

3.0111

2.8739

2.8102

2.7217

2.6432

2.6007.

3. A method of claim 1 wherein the nicotine withdrawal or dependence is from the smoking of tobacco.

4. A method of claim 3 wherein the nicotine withdrawal or dependence is from the smoking of cigarettes.

5. A method of claim 1 wherein the nicotine dependence is selected from the group consisting of Nicotine Dependence, with physiological dependence;

Nicotine Dependence, without physiological dependence;

Nicotine Dependence, Early Full Remission;

Nicotine Dependence, Early Partial Remission;

Nicotine Dependence, Sustained Full Remission;

Nicotine Dependence, Sustained Partial Remission; and

Nicotine Dependence, On Agonist Therapy.

6. A method of claim 1 wherein the mammal is suffering from Nicotine Withdrawal.

7. A method of claim 1 wherein the nicotine withdrawal or dependence is from the oral ingestion of tobacco.

8. A method of claim 2 wherein the nicotine dependence is selected from the group consisting of Nicotine Dependence, with physiological dependence;

Nicotine Dependence, without physiological dependence;

Nicotine Dependence, Early Full Remission;

Nicotine Dependence, Early Partial Remission;

Nicotine Dependence, Sustained Full Remission;

Nicotine Dependence, Sustained Partial Remission; and

Nicotine Dependence, On Agonist Therapy.

9. A method of claim 2 wherein the mammal is suffering from Nicotine Withdrawal.

10. A method of claim 1 wherein the effective amount is from about 1 mg to about 20 mg per day.

11. A method of claim 1 wherein the mammal is a human.

12. A method of claim 3 wherein the mammal is a human.

13. A method of claim 4 wherein the mammal is a human.

14. A method of claim 2 wherein the mammal is a human.

15. A method of claim 8 wherein the mammal is a human.

16. A method of claim 9 wherein the mammal is a human.

17. A method of claim 10 wherein the mammal is a human.