METHOD OF PROVIDING PIRFENIDONE THERAPY TO A PATIENT

• US 20090197923A1
• Filed: 04/21/2009
• Published: 08/06/2009
• Est. Priority Date: 12/18/2006
• Status: Active Grant

• Current Assignee: Intermune Incorporated (Roche Holding AG)
• Original Assignee: Intermune Incorporated (Roche Holding AG)
• Inventors: Bradford, Williamson Z.
• Granted Patent: US 7,696,236 B2
• Time in Patent Office: Days
• US Class Current: 514/350
• CPC Class Codes: A61J 1/03 for pills or tablets containers for pills or tablets with special dispensing means therefor B65D83/04
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61J 2205/50 using icons or symbolic figures, e.g. by a graphical representation symbolising the type of pathology or the organ by an image
• CPC Class Codes: A61K 31/4412 having oxo groups directly attached to the heterocyclic ring
• CPC Class Codes: A61K 31/4418 having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
• 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 17/02 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 37/00 Drugs for immunological or allergic disorders
• 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 decreasing adverse events associated with pirfenidone (5-methyl-1-phenyl-2-(1H)-pyridone) therapy. The invention discloses an optimized dose escalation scheme that results in the patient having increased tolerance to adverse events associated with the administration of pirfenidone. The invention also discloses a starter pack that may be used in conjunction with the dose escalation scheme.

Claims

1. A method of providing pirfenidone therapy to a patient for the treatment of idiopathic pulmonary fibrosis comprising:

providing a first oral daily dosage of pirfenidone to a patient for a first period of time;

providing a second oral daily dosage of pirfenidone greater than the first daily dosage to the patient for a second period of time; and

providing a third oral daily dosage of pirfenidone greater than the second daily dosage to the patient for a third period of time after said first and second periods of time, wherein the first and second periods of time total at least 14 days and wherein the third daily dosage is greater than 1800 mg and is 2403 mg or less.

2. The method according to claim 1, further comprising instructing the patient to take said daily dosages with food.

3. The method according to claim 1, wherein the first dosage is 801 mg.

4. The method according to claim 1, wherein the second dosage is 1,602 mg.

5. The method according to claim 1, wherein the third dosage is 2,403 mg.

6. The method according to claim 1, wherein the first period of time is 7 days.

7. The method according to claim 1, wherein the second period of time is 7 days.

8. The method according to claim 1 wherein the first dosage is 801 mg per day for 7 days.

9. The method according to claim 1, wherein the third period of time is at least one day.

10. The method according to claim 9, wherein the third period of time is more than one day.

11. The method according to claim 1 comprising:

providing a first daily dosage of pirfenidone to the patient in an amount of 801 mg over the course of seven days;

providing a second daily dosage of pirfenidone to the patient in an amount of 1602 mg over the course of the next seven days; and

providing a third daily dosage of pirfenidone to the patient in an amount of 2403 mg for at least one subsequent day.

12. The method according to claim 11,

wherein the first daily dosage comprises one capsule comprising 267-mg of pirfenidone three times a day;

wherein the second daily dosage comprises two capsules comprising 267-mg of pirfenidone three times a day; and

wherein the third daily dosage comprises three capsules comprising 267-mg of pirfenidone three times a day.

13. A method of providing pirfenidone therapy to a patient for the treatment of idiopathic pulmonary fibrosis, comprising:

providing pirfenidone to a patient at a first oral daily dosage of 801 mg as one capsule comprising 267-mg of pirfenidone three times a day for seven days;

providing a second oral daily dosage of 1602 mg as two capsules comprising 267-mg of pirfenidone three times a day for the next seven days;

providing a third oral daily dosage of 2403 mg as three capsules comprising 267-mg of pirfenidone three times a day for at least one subsequent day; and

instructing said patient to take said dosages with food, wherein the patient is provided pirfenidone for the treatment of idiopathic pulmonary fibrosis.

14. The method according to claim 13 wherein the incidence of adverse events is decreased in patients receiving pirfenidone therapy relative to patients receiving a maximum dose of 1800 mg/day at day 5 of therapy.

15. The method of claim 14 wherein the incidence of photosensitivity reaction is decreased in patients receiving pirfenidone therapy relative to patients receiving a maximum dose of 1800 mg/day at day 5 of therapy.