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Claims for Patent: 8,112,290

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Claims for Patent: 8,112,290

Title:Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug
Abstract: Novel methods for delivering a drug to hospital patients for short-term in-hospital use while minimizing long-term use of the drug. Embodiments are provided in which hospitals are identified which may be eligible to treat patients, for example, perform certain types of surgery, and which have measures in place to limit use of the drug to short-term use. The identified hospitals are preferably registered in a storage medium, including computer readable storage media, and may be authorized to receive the shipments of the drug. The received drug may then be dispensed to the patient.
Inventor(s): Maurer; George Raymond (Dunellen, NJ), Jones; Robert Barnett (Summit, NJ)
Assignee: Adolor Corporation (Exton, PA)
Application Number:12/467,016
Patent Claims: 1. A method for delivering a drug to hospital patients for short-term use while minimizing long-term use of the drug, wherein the drug requires compliance with a risk evaluation and mitigation strategy approved by the Food and Drug Administration (FDA) which is designed to minimize the occurrence of an observed adverse event; and wherein the method comprises: identifying hospitals that may be eligible to dispense the drug, said eligibility requiring that said hospitals: perform abdominal surgery or are acute care hospitals; and treat patients who are inpatients; providing said identified hospitals with literature regarding use of the drug including dosing recommendations and contraindications, and which describes the observation of an adverse event associated with long-term use of the drug; wherein the drug is a peripherally acting mu-opioid receptor antagonist selected from the group consisting of alvimopan and N-methylnaltrexone; receiving registration information from said identified hospitals; identifying a subpopulation of said identified hospitals which treat the patients and which have said measures in place to limit use of the drug to short-term use; wherein said measures comprise order sets, protocols or guidelines, residing on an integrated information system, including a data processing machine, to limit use of the drug to short-term use; registering said subpopulation in a computer readable storage medium; authorizing said subpopulation to receive shipment of the drug; and dispensing the drug to the patients in said subpopulation for short-term use; wherein the patients are hospital inpatients and the delivery is limited to in-hospital administration; and monitoring the patients for said observed adverse event.

2. A method according to claim 1 wherein long-term use of the drug is associated with the observation of an adverse event.

3. A method according to claim 2 wherein said observed adverse event is an ischemic cardiovascular event.

4. A method according to claim 3 wherein said ischemic cardiovascular event is a myocardial infarction.

5. A method according to claim 1 wherein the patients are acute care patients.

6. A method according to claim 5 wherein said acute care patients are abdominal surgery patients.

7. A method according to claim 6 wherein said abdominal surgery is bowel resection surgery.

8. A method according to claim 6 wherein the delivery of the drug to said abdominal surgery patients is for the treatment or prevention of gastrointestinal dysfunction.

9. A method according to claim 8 wherein said gastrointestinal dysfunction is ileus.

10. A method according to claim 1 wherein said observed adverse event is an ischemic cardiovascular event.

11. A method according to claim 10 wherein said ischemic cardiovascular event is a myocardial infarction.

12. A method according to claim 1 wherein short-term use comprises the delivery to each of the patients of no more than about 20 doses of the drug.

13. A method according to claim 12 wherein no more than about 15 doses of the drug are delivered to each of the patients.

14. A method according to claim 13 wherein no more than about 10 doses of the drug are delivered to each of the patients.

15. A method according to claim 14 wherein no more than about 7 doses of the drug are delivered to each of the patients.

16. A method according to claim 1 wherein short-term use comprises the delivery to each of the patients of a total of from about 10 to about 20 doses of the drug.

17. A method according to claim 16 wherein a total of from about 14 to about 16 doses of the drug is delivered to each of the patients.

18. A method according to claim 17 wherein a total of about 15 doses of the drug is delivered to each of the patients.

19. A method according to claim 1 wherein short-term use comprises the delivery to each of the patients of a total of from about 4 to about 8 doses of the drug.

20. A method according to claim 19 wherein a total of from about 6 to about 7 doses of the drug is delivered to each of the patients.

21. A method according to claim 6 wherein the drug is delivered to said abdominal surgery patients prior to surgery, after surgery, or both prior to and after surgery.

22. A method according to claim 21 wherein short-term use comprises the delivery of the drug to said abdominal surgery patients for no more than about 10 days after surgery.

23. A method according to claim 22 wherein the drug is delivered to said abdominal surgery patients for no more than about 7 days after surgery.

24. A method according to claim 23 wherein the drug is delivered to said abdominal surgery patients for no more than about 5 days after surgery.

25. A method according to claim 24 wherein the drug is delivered to said abdominal surgery patients for no more than about 3 days after surgery.

26. A method according to claim 21 wherein short-term use comprises the delivery of the drug to said abdominal surgery patients for about 5 to about 10 days after surgery.

27. A method according to claim 26 wherein the drug is delivered to said abdominal surgery patients for about 6 to about 8 days after surgery.

28. A method according to claim 27 wherein the drug is delivered to said abdominal surgery patients for about 7 days after surgery.

29. A method according to claim 21 wherein short-term use comprises the delivery of the drug to said abdominal surgery patients for more than about 1 to about 4 days after surgery.

30. A method according to claim 29 wherein the drug is delivered to said abdominal surgery patients for about 2 to about 3 days after surgery.

31. A method according to claim 21 wherein the drug is delivered to said abdominal surgery patients about twice a day after surgery.

32. A method according to claim 21 wherein short-term use comprises the delivery to each of said abdominal surgery patients of a total of from about 10 to about 20 doses of the drug after surgery.

33. A method according to claim 32 wherein a total of from about 12 to about 15 doses of the drug is delivered to each of said abdominal surgery patients after surgery.

34. A method according to claim 33 wherein a total of about 14 doses of the drug is delivered to each of said abdominal surgery patients after surgery.

35. A method according to claim 21 wherein short-term use comprises the delivery to each of said abdominal surgery patients of a total of from about 5 to about 8 doses of the drug after surgery.

36. A method according to claim 35 wherein a total of from about 6 to about 7 doses of the drug is delivered to each of said abdominal surgery patients after surgery.

37. A method according to claim 21 wherein the drug is delivered to said abdominal surgery patients for less than about 1 day to about 5 days prior to surgery.

38. A method according to claim 37 wherein the drug is delivered to said abdominal surgery patients for less than about 1 day to about 2 days prior to surgery.

39. A method according to claim 38 wherein the drug is delivered to said abdominal surgery patients for less than about 1 day to about 1 day prior to surgery.

40. A method according to claim 21 wherein about 0 to about 5 doses of the drug are delivered to each of said abdominal surgery patients prior to surgery.

41. A method according to claim 40 wherein about 1 to about 3 doses of the drug are delivered to each of said abdominal surgery patients prior to surgery.

42. A method according to claim 41 wherein about 1 dose of the drug is delivered to each of said abdominal surgery patients prior to surgery.

43. A method according to claim 1 wherein the drug is alvimopan.

44. A method according to claim 43 wherein said alvimopan is formulated for oral administration.

45. A method according to claim 44 wherein said alvimopan is in the form of a hot-melt gelatin capsule.

46. A method according to claim 45 wherein said hot-melt gelatin capsule comprises alvimopan suspended in water-soluble polyethylene glycol.

47. A method according to claim 44 wherein each dose delivered to each of the patients contains from about 5 to about 20 mg alvimopan.

48. A method according to claim 47 wherein each of said doses contains from about 10 to about 15 mg alvimopan.

49. A method according to claim 48 wherein each of said doses contains about 12 mg alvimopan.

50. A method according to claim 43 wherein said alvimopan is formulated for intravenous administration.

51. A method according to claim 50 wherein each dose delivered to each of the patients contains from about 0.5 to about 5 mg alvimopan.

52. A method according to claim 51 wherein each of said doses contains from about 1 to about 3 mg alvimopan.

53. A method according to claim 1 further comprising the step of: (g') transferring said drug from a hospital in said subpopulation to one or more additional hospitals for delivery to a patient within said one or more additional hospitals, provided that: (i) said one or more additional hospitals have been provided with literature regarding use of the drug; and (ii) said one or more additional hospitals treat said patients and have measures in place to limit use of the drug to short-term use.

54. A method according to claim 53 further comprising the step of: (h) dispensing the drug to said patients in said one or more additional hospitals for short-term use.
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