Methods of reducing adverse events associated with pirfenidone therapy

• US 20070203202A1
• Filed: 11/28/2006
• Published: 08/30/2007
• Est. Priority Date: 12/02/2005
• Status: Abandoned Application

• Current Assignee: Intermune Incorporated (Roche Holding AG)
• Original Assignee: Intermune Incorporated (Roche Holding AG)
• Inventors: Freemer, Michelle, Loutit, Jeffery, Robinson, Cynthia
• Application Number:
  US11/605,199
• Publication Number:
  US 20070203202A1
• Time in Patent Office: Days
• US Class Current: 514/345
• CPC Class Codes: A23K 20/111 Aromatic compounds
• CPC Class Codes: A23L 33/105 Plant extracts, their artificial duplicates or their derivatives
• CPC Class Codes: A61K 31/4412 having oxo groups directly attached to the heterocyclic ring
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to methods for reducing adverse events in patients receiving pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy.

Claims

1. A method of reducing adverse events in a patient receiving pirfenidone therapy comprising administering to the patient a pharmaceutical composition with food, wherein the composition comprises a therapeutically effective amount of pirfenidone, and wherein the administering comprises providing greater than 1800 mg/day of pirfenidone to the patient.

2. The method of claim 1, wherein the patient is a human.

3. The method of claim 1 or 2, wherein the administering comprises orally administering the pharmaceutical composition.

4. The method of any one of claims 1-3, wherein the administering to the patient occurs between 30 minutes prior to and 2 hours after consuming food.

5. The method of any one of claims 1-4, wherein the administering to the patient is substantially at the same time as the consumption of the food.

6. The method of any one claims 1-5, wherein the administering to the patient is immediately after the consumption of food up to 1 hour after said consumption.

7. The method of any one of claims 1-6, wherein the administering with food comprises administering pirfenidone with a meal.

8. The method of any one of claims 1-7, wherein the administering comprises providing a unit dosage form comprising pirfenidone.

9. The method of any one of claims 1-8, wherein the administering comprises providing a tablet or capsule, wherein the tablet or capsule comprises pirfenidone.

10. The method of any one of claims 1-9, wherein the administering comprises providing one or more of tablets or capsules comprising pirfenidone to the patient one or more times per day.

11. The method of any one of claims 1-10, wherein the administering comprises providing one or more of capsules comprising pirfenidone to the subject twice per day.

12. The method of any one of claims 1-11, wherein the administering comprises providing one or more capsules comprising pirfenidone to the subject three times per day.

13. The method of any one of claims 1-12, wherein the administering comprises providing a unit dosage form of pirfenidone, wherein the unit dosage form comprises about 100 to about 400 milligrams of pirfenidone per unit.

14. The method of any one of claims 1-13, wherein the administering comprises providing a unit dosage form of pirfenidone, wherein the unit dosage form comprises about 267 milligrams of pirfenidone per unit.

15. The method of any one of claims 1-14, wherein the administering comprises providing from about 2000 mg/day to about 4000 mg/day of pirfenidone to the patient.

16. The method of any one of claims 1-15, wherein the administering comprises providing from about 2200 mg/day to about 4000 mg/day of pirfenidone to the patient.

17. The method of any one of claims 1-16, wherein the administering comprises providing from about 2400 mg/day to about 4000 mg/day of pirfenidone to the patient.

18. The method of any one of claims 1-17, wherein the administering comprises providing about 2403 mg/day of pirfenidone to the patient.

19. The method of any one of claims 1-18, further comprising advising the patient that the administration of the pharmaceutical composition with food results in a reduction in the likelihood of adverse events.

20. The method of any one of claims 1-19, wherein the administering comprises providing said pharmaceutical composition to the patient in a container associated with printed labeling advising the patient that the pharmaceutical composition is to be administered with food.

21. The method of any one of claims 1-20, wherein the adverse event is nausea.

22. The method of any one of claims 1-20, wherein the adverse event is somnolence.

23. The method of any one of claims 1-20, wherein the adverse event is headache.

24. A kit comprising a pharmaceutical composition, prescribing information, and a container, wherein the pharmaceutical composition comprises a therapeutically effective amount of pirfenidone.

25. The kit of claim 24, wherein the prescribing information advises a patient to take the pharmaceutical composition with food.

26. The kit of any claim 24 or 25, wherein a tablet or capsule comprises the composition.

27. The kit of claim 26, wherein the prescribing information advises the patient to take one or more of the tablets or capsules one or more times per day.

28. The kit of any one of claims 24-27, wherein the composition comprises a unit dosage form comprising from about 100 to about 400 milligrams of pirfenidone per unit.

29. A method for providing pirfenidone therapy to a patient, comprising:

providing a therapeutic dose of pirfenidone to the patient; and

advising the patient to take the pirfenidone with food.

30. A method for providing pirfenidone therapy to a patient, comprising:

providing a therapeutic dose of pirfenidone to the patient; and

advising the patient that consuming the pirfenidone with food may reduce the incidence of adverse events resulting from pirfenidone therapy.

31. A method for providing pirfenidone therapy to a patient, comprising:

providing a therapeutic dose of pirfenidone to the patient; and

advising the patient that consuming the pirfenidone with food reduces mean maximum plasma concentration of pirfenidone.

32. The method of claim 31, further comprising advising the patient that consuming 801 mg pirfenidone with food reduces mean maximum plasma concentration of pirfenidone from 15724 ng/mL to 7874 ng/mL in comparison to consuming the pirfenidone without food.

33. The method of claim 31, further comprising advising the patient that consuming 801 mg pirfenidone with food increases mean absorption half life of the pirfenidone from 0.572 hours to 1.78 hours in comparison to consuming the pirfenidone without food.

34. The method of claim 31, wherein the patient is advised in writing.

35. The method of claim 31, wherein the patient is advised orally.