Methods for slowing the progression of multiple sclerosis

• US 20080175902A1
• Filed: 11/28/2007
• Published: 07/24/2008
• Est. Priority Date: 11/30/2006
• Status: Abandoned Application

• Current Assignee: University Of Plymouth Enterprise Limited (University of Plymouth)
• Original Assignee: University of Plymouth
• Inventors: Zajicek, John
• Application Number:
  US11/998,373
• Publication Number:
  US 20080175902A1
• Time in Patent Office: Days
• US Class Current: 424/456
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system

Abstract

Methods are provided herein for slowing the progression of multiple sclerosis comprising administering a therapeutically effective amount of a cannabinoid to a patient suffering from MS.

Claims

1. A method of slowing the progression of multiple sclerosis in a patient in need thereof comprising administration of a pharmaceutical composition comprising an effective amount of a therapeutically effective cannabinoid on a regular basis;

the administration occurring over a period of time selected from the group consisting of at least about 16 weeks, at least about 27 weeks, at least about 40 weeks and at least about 52 weeks.

2. The method of claim 1, wherein the cannabinoid comprises a natural cannabinoid.

3. The method of claim 1, wherein the cannabinoid comprises a synthetic cannabinoid.

4. The method of claim 1, wherein the cannabinoid comprises a semi-synthetic cannabinoid.

5. The method of claim 1, wherein the cannabinoid is selected from the group consisting of one or more (i) natural cannabinoids that have been purified or modified;

(ii) synthetically derived cannabinoids;

(iii) semi-synthetic cannabinoids;

(iv) esterified cannabinoids;

(v) active metabolites of any of the foregoing, (vi) pro-drugs of any of the foregoing; and

(vii) mixtures thereof.

6. The method of claim 1, wherein the cannabinoid comprises D9-THC.

7. The method of claim 1, wherein the cannabinoid comprises THC-hemisuccinate.

8. The method of claim 1 wherein the patient displays an improvement in at least one indicator of progression of multiple sclerosis selected from the group consisting of Ashworth score, Rivermead Mobility Index value and timed 10 metre walk compared to a group of patients administered placebo over at least about 16 weeks.

9. The method of claim 8 wherein the patient displays an improvement in Ashworth score, compared to a group of patients administered placebo over at least about 16 weeks.

10. The method of claim 8 wherein the patient displays an improvement in Rivermead Mobility index, compared to a group of patients administered placebo over at least about 16 weeks.

11. The method of claim 8 wherein the patient displays significant improvement in Rivermead Mobility index, compared to a group of patients administered placebo over at least about 16 weeks.

12. The method of claim 8 wherein the patient displays an improvement in 10 metre walk time, compared to a group of patients administered placebo over at least about 16 weeks.

13. The method of claim 8 wherein the patient displays a significant improvement in at least one symptom selected from the group consisting of pain, spasms, spasticity and sleep, compared to a group of patients administered placebo over at least about 16 weeks.

14. The method of claim 1 wherein said composition is orally administered.

15. The method of claim 14 wherein the composition is encapsulated in a gelatin or non-gelatin shell.

16. The method of claim 14 wherein the cannabinoid is present in either a liquid solution or liquid suspension.

17. The method of claim 16 wherein the liquid is a hydrophobic material, a hydrophilic material or an amphiphilic material.

18. The method of claim 17 wherein the liquid is selected from the group consisting of an oil, water or an alcohol.

19. The method of claim 18 wherein the liquid is sesame oil.

21. The method of claim 1 wherein the patient exhibits an increase of about 0.2 to about 1.1 in Rivermead Mobility Index values at about 12-27 weeks of administration compared to a group of patients administered placebo over at least about 16 weeks.

22. The method of claim 1 wherein the patient exhibits an increase of about 0.25 to about 1.3 in Rivermead Mobility Index values at about 25-40 weeks of administration compared to a group of patients administered placebo over at least about 16 weeks.

23. The method of claim 1 wherein the patient exhibits an increase of about 0 to about 1.2 in Rivermead Mobility Index values at about 35-50 weeks of administration compared to a group of patients administered placebo over at least about 16 weeks.

24. The method of claim 1 wherein the patient exhibits a change in Ashworth scores of from about −

1 to about 2.5 at about 12-27 weeks of administration compared to a group of patients administered placebo over at least about 16 weeks.

25. The method of claim 1 wherein the patient exhibits a change in Ashworth scores of from about −

5 to about 3.5 at about 25-40 weeks of administration compared to a group of patients administered placebo over at least about 16 weeks.

26. The method of claim 1 wherein the patient exhibits an increase in Ashworth scores of from about 0.2 to about 4 at about 35-50 weeks of administration compared to a group of patients administered placebo over at least about 16 weeks.

27. The method of claim 1 wherein composition is administered in a dosage form selected from the group consisting of an intranasal solution, an intranasal suspension, an inhalant solution, an inhalant suspension, a parenteral solution, a parental suspension, a transdermal patch, a transdermal gel, a transdermal cream, a transdermal ointment, and a transdermal lotion.

28. 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 oral inhalant, a nasal inhalant, an injectable, a transdermal, a sublingual, and a suppository.

29. The method of claim 1 wherein the capsule is a soft gelatin or HPMC capsule.

30. The method of claim 1 wherein the composition is administered in combination with one or more multiple sclerosis therapies.

31. The method of claim 6 wherein the composition is administered in an amount sufficient to provide from about 2.5 mg D9-THC to about 20 mg D9-THC per day.

32. The method of claim 6 wherein the composition is administered in an amount sufficient to provide about 2.5 mg D9-THC per day.

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

20. A method of slowing the progression of multiple sclerosis in a patient in need thereof comprising administering on a regular basis, an oral pharmaceutical composition comprising an effective amount of D9-THC, an oil and a capsule.