METHODS FOR REDUCING THE OCCURRENCE OF PRETERM DELIVERY AND OTHER PREGNANCY-RELATED CONDITIONS

• US 20110152840A1
• Filed: 12/17/2010
• Published: 06/23/2011
• Est. Priority Date: 12/23/2009
• Status: Abandoned Application

• Current Assignee: Lumara Health IP Ltd. (Apollo Global Management, Inc.)
• Original Assignee: DrugTech Corporation (PD International Holdings LLC)
• Inventors: Lee, Chang, Birch, Robert
• Application Number:
  US12/971,900
• Publication Number:
  US 20110152840A1
• Time in Patent Office: Days
• US Class Current: 604/522
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 5/30 Oestrogens

Abstract

The present invention relates to methods and kits for reducing the occurrence of preterm delivery and other pregnancy-related conditions in pregnant female subjects exhibiting one or more risk factors for preterm delivery and other pregnancy-related conditions. For example, the present invention relates to methods for reducing the occurrence of preterm delivery in a pregnant female subject having no history of preterm delivery and exhibiting one or more risk factors for preterm delivery (e.g., smoking during pregnancy). The methods and kits provide for the administration of a steroid hormone to the pregnant female subject.

Claims

1. A method for reducing the occurrence of preterm delivery, the method comprising:

administering a pharmaceutical composition comprising a steroid hormone to a pregnant female subject having no history of preterm delivery and exhibiting one or more risk factors for preterm delivery selected from the group consisting of exposure to tobacco smoke, exposure to tobacco smoke residue, use of smokeless tobacco, substance use or abuse or dependence, alcohol use or abuse or dependence, stress, anxiety, depression, poor nutritional status, insufficient weight gain during pregnancy, advanced maternal age, low socio-economic status, and combinations thereof.

2. A method for reducing the occurrence of preterm delivery, the method comprising:

administering a pharmaceutical composition comprising a steroid hormone to a pregnant female subject having no history of preterm delivery, wherein the pregnant female subject is at risk for preterm delivery due to exposure to tobacco smoke.

3. The method of claim 2 wherein the exposure to tobacco smoke comprises smoking by the pregnant female subject during pregnancy.

5. The method of claim 2 further comprising evaluating whether the pregnant female subject exhibits the one or more risk factors.

6. The method of claim 2 wherein the steroid hormone is a progestogen.

7. The method of claim 2 wherein the pharmaceutical composition is administered beginning at between about 1 week and about 35 weeks of gestation.

8. The method of claim 7 wherein administration continues to about 37 weeks of gestation, or delivery.

13. The method of claim 2 wherein the pregnant female subject is a primigravida.

14. The method of claim 2 wherein the pharmaceutical composition is administered at an interval exceeding once per week.

16. The method of claim 2 wherein the pharmaceutical composition is administered once monthly.

17. The method of claim 2 wherein the pharmaceutical composition is administered once weekly.

18. The method of claim 2 wherein the pharmaceutical composition is administered at an interval of less than one week.

19. The method of claim 2 wherein the pharmaceutical composition is administered by a method selected from the group consisting of injections, rectal delivery, transdermal delivery, intravaginal delivery, and oral delivery.

21. The method of claim 19 wherein the injection is a subcutaneous or intramuscular depot injection.

24. The method of claim 6 wherein the progestogen is a progestin.

25. The method of claim 6 wherein the progestogen is selected from the group consisting of a pregnane or a derivative thereof, a norpregnane or a derivative thereof, an estrane or a derivative thereof, a gonane or a derivative thereof, and combinations thereof.

26. The method of claim 6 wherein the progestogen is selected from the group consisting of progesterones, retroprogesterones, 17alpha-hydroxyprogesterone derivatives, 17alpha-hydroxynorprogesterone derivatives, 19-norprogesterone derivatives, 19-nortestosterone derivatives, and combinations thereof.

27. The method of claim 6 wherein the progestogen is selected from the group consisting of 17alpha-hydroxyprogesterone or a derivative thereof, natural progesterone, dydrogesterone or a derivative thereof, medrogestone or a derivative thereof, medroxyprogesterone or a derivative thereof, megestrol or a derivative thereof, chlormadinone or a derivative thereof, cyproterone or a derivative thereof, gestonorone or a derivative thereof, nomegestrol or a derivative thereof, demegestone or a derivative thereof, promegestone or a derivative thereof, nestorone or a derivative thereof, trimegestone or a derivative thereof, norethisterone or a derivative thereof, lynestrenol or a derivative thereof, ethynodiol or a derivative thereof, norgestrel or a derivative thereof, levonorgestrel or a derivative thereof, desogestrel or a derivative thereof, etonogestrel (3-keto-desogestrel) or a derivative thereof, gestodene or a derivative thereof, norgestimate or a derivative thereof, norelgestromin (17-deacetyl norgestimate) or a derivative thereof, dienogest or a derivative thereof, drospirenone or a derivative thereof, norethindrone or a derivative thereof, norethynodrel or a derivative thereof, and combinations thereof.

29. The method of claim 27 wherein the derivative of 17alpha-hydroxyprogesterone is a carboxylic acid ester of 17alpha-hydroxyprogesterone.

30. The method of claim 2 wherein the pharmaceutical composition comprises 17alpha-hydroxyprogesterone caproate (17-HPC).

31. The method of claim 2 wherein the pharmaceutical composition is administered to the pregnant female subject as a depot injection at an interval exceeding once weekly, wherein the composition comprises from about 100 mg to about 3000 mg of 17-HPC.

33. The method of claim 2 wherein the pharmaceutical composition is administered to the pregnant female subject as a once-weekly depot injection comprising from about 50 mg to about 1600 mg of 17-HPC.

37. The method of claim 2 wherein the pregnant female subject is at risk for preterm delivery due to a risk factor selected from the group consisting of exposure to tobacco smoke due to smoking by the pregnant female subject during pregnancy, exposure to tobacco smoke due to exposure to environmental tobacco smoke during pregnancy, exposure to tobacco smoke residue on environmental surfaces, and combinations thereof.

39. The method of claim 2 further comprising one or more additional treatments for reducing the occurrence of preterm delivery.

40. The method of claim 39 wherein the one or more additional treatments are selected from the group consisting of behavior modification, stress reduction or counseling, early access to care, administration or prescription of one or more pharmaceutical products, administration or prescription of one or more nutritional products, reduced physical activity, one or more surgical interventions, and combinations thereof.

42. The method of claim 3 further comprising the administration of one or more smoking cessation products and/or therapies prior to and/or concurrently with the administration of the pharmaceutical composition comprising a steroid hormone.

50. The method of claim 2 further comprising treating a smoking-related disease or disorder.

4. A method for reducing the occurrence of one or more conditions selected from the group consisting of delivery of low birth weight neonates, delivery of small for gestational age neonates, pregnancy-related complications, fetal mortality, neonatal morbidity, neonatal mortality, infant morbidity, infant mortality, childhood developmental delays, and combinations thereof, the method comprising:

administering a pharmaceutical composition comprising a steroid hormone to a pregnant female subject having no history of preterm delivery and exhibiting one or more risk factors for the one or more conditions, the one or more risk factors selected from the group consisting of exposure to tobacco smoke, exposure to tobacco smoke residue, use of smokeless tobacco, substance use or abuse or dependence, alcohol use or abuse or dependence, stress, anxiety, depression, poor nutritional status, insufficient weight gain during pregnancy, advanced maternal age, low socio-economic status, and combinations thereof.

9-12. -12. (canceled)

15. (canceled)

20. (canceled)

22-23. -23. (canceled)

28. (canceled)

32. (canceled)

34-36. -36. (canceled)

38. (canceled)

41. (canceled)

43-49. -49. (canceled)

51. (canceled)

52. A kit comprising

a pharmaceutical composition comprising a steroid hormone and one or more pharmaceutically acceptable excipients;

and

instructions for administering the pharmaceutical composition to a pregnant female subject to reduce the occurrence of preterm delivery, the pregnant female subject having no history of preterm delivery and exhibiting one or more risk factors for preterm delivery selected from the group consisting of exposure to tobacco smoke, exposure to tobacco smoke residue, use of smokeless tobacco, substance use or abuse or dependence, alcohol use or abuse or dependence, stress, anxiety, depression, poor nutritional status, insufficient weight gain during pregnancy, advanced maternal age, low socio-economic status, and combinations thereof.

53. A kit comprising

a pharmaceutical composition comprising a steroid hormone and one or more pharmaceutically acceptable excipients;

and

instructions for administering the pharmaceutical composition to a pregnant female subject to reduce the occurrence of preterm delivery, the pregnant female subject having no history of preterm delivery, wherein the pregnant female subject is at risk for preterm delivery due to exposure to tobacco smoke.

54. The kit of claim 53 wherein the exposure to tobacco smoke comprises smoking by the pregnant female subject during pregnancy.

57. The kit of claim 53 wherein the steroid hormone is a progestogen.

81. The kit of claim 53 wherein the pharmaceutical composition comprises 17alpha-hydroxyprogesterone caproate (17-HPC).

55. A kit comprising

a pharmaceutical composition comprising a steroid hormone and one or more pharmaceutically acceptable excipients;

and

instructions for administering the pharmaceutical composition to a pregnant female subject to reduce the occurrence of one or more conditions selected from the group consisting of delivery of low birth weight neonates, delivery of small for gestational age neonates, pregnancy-related complications, fetal mortality, neonatal morbidity, neonatal mortality, infant morbidity, infant mortality, childhood developmental delays, and combinations thereof, the pregnant female subject having no history of preterm delivery and exhibiting one or more risk factors for the one or more conditions, the one or more risk factors selected from the group consisting of exposure to tobacco smoke, exposure to tobacco smoke residue, use of smokeless tobacco, substance use or abuse or dependence, alcohol use or abuse or dependence, stress, anxiety, depression, poor nutritional status, insufficient weight gain during pregnancy, advanced maternal age, low socio-economic status, and combinations thereof.

56. (canceled)

58-80. -80. (canceled)

82-102. -102. (canceled)

103. A method for treating a smoking-related disease or disorder, the method comprising:

administering a pharmaceutical composition comprising a progestogen to a subject suffering from a smoking-related disease or disorder.

104-105. -105. (canceled)