Surfactant treatment regimen

• US 20060194728A1
• Filed: 01/06/2006
• Published: 08/31/2006
• Est. Priority Date: 01/06/2005
• Status: Active Grant

• Current Assignee: Windtree Therapeutics, Inc.
• Original Assignee: Discovery Laboratories, Inc.
• Inventors: Segal, Robert, Killian, Anthony, Guardia, Carlos, Schaber, Christopher
• Granted Patent: US 7,541,331 B2
• Time in Patent Office: Days
• US Class Current: 514/120
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 38/395 Alveolar surfactant peptides; Pulmonary surfactant peptides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/08 Bronchodilators

Abstract

Regimens for the therapeutic or prophylactic administration of pulmonary surfactant to infants exhibiting or at risk of developing bronchopulmonary dysplasia are disclosed.

Claims

1. A method for treating or preventing bronchopulmonary dysplasia in an infant treated with pulmonary surfactant for respiratory distress syndrome, the method comprising:

following the treatment for respiratory distress syndrome with pulmonary surfactant, administering pulmonary surfactant to the infant in an amount and for a time effective to treat or prevent the bronchopulmonary dysplasia.

2. The method of claim 1 wherein the administering is initiated at the next dosage interval following completion of the treatment for respiratory distress syndrome with pulmonary surfactant.

3. The method of claim 1 wherein the administering is initiated at day 3 of life of the infant.

4. The method of claim 1 wherein the administering is continued through at least 36 weeks post-menstrual age of the infant.

5. The method of claim 1 wherein the administering is continued through at least 28 days post-natal age of the infant.

6. The method of claim 1 wherein the administering is continued through at least day 14 of life of the infant.

7. The method of claim 1 wherein the administering is continued through at least day 18 of life of the infant.

8. The method of claim 3 wherein the administering is initiated at day 3 of life of the infant and is continued through at least day 14 of life of the infant

9. The method of claim 1 wherein the administering is initiated anytime from day 3 to day 14 of life of the infant.

10. The method of claim 9 wherein the administering is initiated anytime from day 3 to day 10 of life of the infant.

11. The method of claim 1 wherein the method comprises preventing bronchopulmonary dysplasia.

12. The method of claim 1 wherein administration is by endotracheal administration.

13. The method of claim 1 wherein administration is by inhalation.

14. The method of claim 1 wherein the administering is accompanied by another respiratory therapy.

15. The method of claim 14 wherein the other respiratory therapy is conventional ventilation, high frequency ventilation or continuous positive airway pressure.

16. The method of claim 14 wherein the other respiratory therapy is administration of one or more therapeutic agents.

17. The method of claim 16 wherein the other therapeutic agents are nitric oxide, steroids, antioxidants, vitamins, vitamin derivatives, reactive oxygen scavengers, bronchodilators, diuretics, antimicrobial agents, anti-infective agents, anti-hypertensive agents or anti-inflammatory agents.

18. The method of claim 1 comprising administering a synthetic pulmonary surfactant.

19. The method of claim 18 wherein the synthetic pulmonary surfactant comprises a peptide having SEQ ID NO:

1.

20. A method for treating or preventing bronchopulmonary dysplasia in an infant requiring respiratory support, the method comprising administering pulmonary surfactant to the infant in an amount and for a time effective to treat or prevent the bronchopulmonary dysplasia.

21. The method of claim 20 wherein the method comprises preventing bronchopulmonary dysplasia.

22. The method of claim 20 wherein the treatment with pulmonary surfactant is administered until the infant no longer requires respiratory support.

23. The method of claim 20 wherein the administering is initiated at or after day 1 of life of the infant and is continued through at least 36 weeks post-menstrual age of the infant.

24. The method of claim 20 wherein the administering is initiated at or after day 1 of life of the infant and continued through at least 28 days post-natal age of the infant.

25. The method of claim 20 wherein the administering is initiated at day 1 of life of the infant.

26. The method of claim 20 wherein the administering is initiated at day 3 of life of the infant.

27. The method of claim 20 wherein the administering is initiated before the infant has been diagnosed with BPD and the infant is treated with pulmonary surfactant at least once after day 2 of life of the infant.

28. The method of claim 27 wherein the infant is treated with pulmonary surfactant at least once after day 3 of life of the infant.

29. The method of claim 27 wherein the administering is initiated at day 1 of life of the infant.

30. The method of claim 29 wherein the administering is continued through at least day 10 of life of the infant.

31. The method of claim 29 wherein the administering is continued through at least day 14 of life of the infant.

32. The method of claim 27 wherein treatment is initiated at day 2 of life the infant.

33. The method of claim 32 wherein treatment is continued through at least day 14 of life of the infant.

34. The method of claim 27 wherein the administering is initiated anytime from day 3 to day 18 of life of the infant.

35. The method of claim 20 wherein the infant does not exhibit respiratory distress syndrome.

36. The method of claim 20 wherein the infant exhibits respiratory distress syndrome.

37. The method of claim 36 wherein pulmonary surfactant is administered to the infant following the episode of respiratory distress syndrome.

38. The method of claim 36 wherein the administering is initiated at or after day 1 of life of the infant and is continued through at least 36 weeks post-menstrual age of the infant.

39. The method of claim 36 wherein the administering is initiated at or after day 1 of life of the infant and continued through at least 28 days post-natal age of the infant.

40. The method of claim 36 wherein the administering is initiated at day 1 of life of the infant.

41. The method of claim 36 wherein the administering is initiated at day 3 of life of the infant.

42. The method of claim 36 wherein the administering is initiated before the infant has been diagnosed with BPD and the infant is treated with pulmonary surfactant at least once after day 2 of life of the infant.

43. The method of claim 42 wherein the infant is treated with pulmonary surfactant at least once after day 3 of life of the infant

44. The method of claim 42 wherein the administering is initiated at day 1 of life of the infant.

45. The method of claim 44 wherein the administering is continued through at least day 10 of life of the infant.

46. The method of claim 44 wherein the administering is continued through at least day 14 of life of the infant.

47. The method of claim 42 wherein treatment is initiated at day 2 of life the infant.

48. The method of claim 47 wherein treatment is continued through at least day 14 of life of the infant.

49. The method of claim 42 wherein the administering is initiated anytime from day 3 to day 18 of life of the infant.

50. The method of claim 20 wherein administration is by endotracheal administration.

51. The method of claim 20 wherein administration is by inhalation.

52. The method of claim 20 wherein the administering is accompanied by another respiratory therapy.

53. The method of claim 52 wherein the other respiratory therapy is conventional ventilation, high frequency ventilation or continuous positive airway pressure.

54. The method of claim 52 wherein the other respiratory therapy is administration of one or more therapeutic agents.

55. The method of claim 54 wherein the other therapeutic agents are nitric oxide, steroids, antioxidants, vitamins, vitamin derivatives, reactive oxygen scavengers, bronchodilators, diuretics, antimicrobial agents, anti-infective agents, anti-hypertensive agents or anti-inflammatory agents.

56. The method of claim 20 comprising administering a synthetic pulmonary surfactant.

57. The method of claim 56 wherein the synthetic pulmonary surfactant comprises a peptide having SEQ ID NO:

1.