Scopolamine to Reduce or Eliminate Hot Flashes, Night Sweats, and Insomnia

• US 20070010550A1
• Filed: 06/02/2006
• Published: 01/11/2007
• Est. Priority Date: 07/08/2005
• Status: Abandoned Application

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: McKenzie, Shirlyn
• Application Number:
  US11/421,960
• Publication Number:
  US 20070010550A1
• Time in Patent Office: Days
• US Class Current: 514/304
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine

Abstract

Compositions and methods of treating or preventing hot flashes, night sweats, and/or insomnia in a subject that involve scopolamine are disclosed. For example, methods of treating hot flashes, night sweats, and/or insomnia in a subject that involve transdermal delivery of scopolamine are set forth herein.

Claims

1. A method of treating or preventing hot flashes, night sweats, and/or insomnia in a subject, comprising administering to the subject a therapeutically effective amount of scopolamine.

2. The method of claim 1, wherein administration is further defined as placing a patch comprising a therapeutically effective amount of scopolamine on a surface of the subject, wherein delivery of scopolamine across the surface of the subject results in prevention or improvement of menopausal symptoms.

3. The method of claim 1, wherein delivery is further defined as transdermal delivery, transmucosal delivery, or transvaginal delivery.

4. The method of claim 1, wherein the subject is a mammal.

5. The method of claim 4, wherein the mammal is a human.

6. The method of claim 1, wherein the subject is further defined as a male or a female with hot flashes, night sweats, and/or insomnia due to hormonal changes.

7. The method of claim 6, wherein the subject is a female with one or more menopausal symptoms.

8. The method of claim 1, wherein the subject is further defined as a patient who has undergone chemotherapy, radiation therapy and/or hormonal therapy for the treatment of cancer.

9. The method of claim 8, wherein the cancer is breast cancer, endometrial cancer, or prostate cancer.

10. The method of claim 1, wherein the subject is a patient who has undergone surgery.

11. The method of claim 10, wherein the surgery is total abdominal hysterectomy with salpingo-oopherectomy, oopherectomy, or prostatectomy.

12. The method of claim 10, wherein the subject is a cancer patient.

13. The method of claim 12, wherein the cancer is breast cancer, endometrial cancer, or prostate cancer.

14. The method of claim 1, wherein the method further comprises identifying a subject in need of treatment or prevention of one or more menopausal symptoms.

15. The method of claim 14, wherein identifying a subject in need of treatment or prevention of hot flashes, night sweats, or insomnia comprises:

a) interviewing a subject to identify a subject affected by or at risk of developing hot flashes, night sweats, or insomnia;

or

b) completion of a questionnaire by a subject to identify a subject affected by or at risk of developing hot flashes, night sweats, or insomnia.

16. The method of claim 1, wherein the subject is a person ineligible for estrogen therapy.

17. The method of claim 16, wherein the subject is ineligible for estrogen therapy because of a history of deep venous thrombosis, stroke, pulmonary embolism, myocardial infarction, endometrial carcinoma, or breast carcinoma.

18. The method of claim 2, wherein the patch is further defined as a transdermal delivery device.

19. The method of claim 18, wherein the transdermal delivery device comprises:

a. a backing layer;

b. a scopolamine reservoir; and

c. an adhesive layer.

20. The method of claim 18, wherein the transdermal delivery device is any of the transdermal delivery devices set forth in U.S. Pat. No. 5,714,162 or U.S. Pat. No. 6,537,571.

21. The method of claim 18, wherein the transdermal delivery device further comprises a membrane controlling the scopolamine flux from the patch to the surface of the subject.

22. The method of claim 19, wherein the scopolamine reservoir is further defined as a pressure sensitive scopolamine reservoir.

23. The method of claim 19, wherein the transdermal delivery device further comprises an additional skin adhesive layer.

24. The method of claim 23, wherein the transdermal delivery device further comprises a peel strip.

25. The method of claim 19, wherein the transdermal delivery device further comprises a protective film.

26. The method of claim 19, wherein the scopolamine reservoir comprises a composition to increase saturation solubility of the scopolamine therein.

27. The method of claim 19, wherein the scopolamine reservoir comprises a composition to decrease saturation solubility of the scopolamine therein.

28. The method of claim 19, wherein the scopolamine reservoir further comprises a composition to increase the solubility of the scopolamine therein.

29. The method of claim 2, wherein the patch comprises about 0.5 to about 5 mg scopolamine.

30. The method of claim 29, wherein the patch comprises about 1.0 to 3.0 mg scopolamine.

31. The method of claim 30, wherein the patch comprises about 1.5 mg scopolamine.

32. The method of claim 2, wherein the patch is applied at a frequency of about every 3 days.

33. The method of claim 1, further comprising administration of one or more secondary therapies for menopausal symptoms.

34. The method of claim 33, wherein the secondary form of therapy is hormonal therapy.

35. The method of claim 34, wherein the hormonal therapy comprises estrogen therapy, progesterone therapy, or a combination of estrogen and progesterone therapy.

36. The method of claim 2, wherein the patch further comprises one or more additional therapeutic agents for treatment or prevention of menopausal symptoms.

37. The method of claim 34, wherein the one or more additional therapeutic agents is selected from the group consisting of an estrogen, progesterone, a synthetic progestin, and bellergal.

38. The method of claim 37, wherein the estrogen is estrone, estradiol-17β

, estriol, or a synthetic estrogen.

39. The method of claim 37, wherein the synthetic progestin is selected from the group consisting of medroxyprogesterone, hydroxyprogesterone, medrogestone and norethindrone.

40. The method of claim 1, further comprising administering one or more agents that counteract one or more side effects of scopolamine.

41. The method of claim 40, wherein the one or more side effects are selected from the group consisting of drowsiness, dry mouth, and dizziness.

42. The method of claim 40, wherein administration of scopolamine is further defined as placing a patch comprising a therapeutically effective amount of scopolamine on a surface of the subject, wherein delivery of scopolamine across the surface of the subject results in prevention or improvement of menopausal symptoms.

43. The method of claim 42, wherein the patch comprises at least one agent that counteracts one or more side effects of scopolamine.

44. The method of claim 2, further defined as a method of administering a composition comprising a therapeutically effective amount of scopolamine and one or more additional agents, wherein the composition comprises bellergal.