Delta-9-THC compositions and methods for treating symptoms associated with multiple sclerosis

• US 20060167084A1
• Filed: 09/16/2005
• Published: 07/27/2006
• Est. Priority Date: 11/05/2003
• Status: Abandoned Application

• Current Assignee: Unimed Pharmaceuticals LLC (Abbott Laboratories)
• Original Assignee: Unimed Pharmaceuticals LLC (Abbott Laboratories)
• Inventors: Dudley, Robert E.
• Application Number:
  US11/227,441
• Publication Number:
  US 20060167084A1
• Time in Patent Office: Days
• US Class Current: 514/454
• CPC Class Codes: A61K 31/536 ortho- or peri-condensed with carbocyclic ring systems
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection

Abstract

Methods are provided for, inter alia, treating and/or preventing symptoms associated with multiple sclerosis and MS relapse.

Claims

1. A method of treating and/or preventing symptoms associated MS in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising delta-9-tetrahydrocannabinol.

2. The method of claim 1 wherein said administering step comprises oral administration.

3. The method of claim 1 wherein said delta-9-tetrahydrocannabinol is administered in the form of one or more capsules containing delta-9-tetrahydrocannabinol in sesame oil.

4. The method of claim 1 wherein the composition comprises a dosage form selected from the group consisting of an intranasal solution or suspension, an inhalant solution or suspension, a parenteral solution or suspension, a transdermal patch, a transdermal gel, and a transdermal cream.

5. The method of claim 1 wherein the composition is administered in a dosage form selected from the group consisting of a tablet, a capsule, an inhalant, an injectable, a transdermal, a sublingual, and a suppository.

6. The method of claim 5 wherein the composition is in the form of an inhalant.

7. The method of claim 6 wherein the inhalant is administered orally.

8. The method of claim 5 wherein the capsule is a soft gelatin or HPMC capsule.

9. The method of claim 1 wherein the composition is administered in combination with one or more MS therapies.

10. The method of claim 1 wherein the delta-9-tetrahydrocannabinol is dronabinol.

11. The method of claim 1 wherein the composition is administered to the patient by a route selected from the group consisting of oral, intranasal, inhalation, injection, transdermal, and sublingual.

12. The method of claim 11 wherein the inhalation comprises oral inhalation.

13. The method of claim 1 wherein the composition is administered in an amount sufficient to provide about 2.5 mg delta-9-tetrahydrocannabinol to about 20 mg delta-9-tetrahydrocannabinol per day.

14. The method of claim 1 wherein the composition is administered in an amount sufficient to provide about 2.5 mg delta-9-tetrahydrocannabinol per day.

15. The method of claim 1 wherein the composition is administered about 1 to about 4 times per day.

16. The method of claim 1 wherein the composition is administered in a single dose.

17. A method of preventing an MS relapse in a subject in need thereof, the method comprising administering to the subject a therapeutically-effective amount of a pharmaceutical composition comprising delta-9-tetrahydrocannabinol.