Method of providing pirfenidone therapy to a patient

• US 8,420,674 B2
• Filed: 07/07/2010
• Issued: 04/16/2013
• 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.
• Primary Examiner(s): Baek, Bong-Sook
• Application Number:
  US12/831,944
• Publication Number:
  US 20100324097A1
• Time in Patent Office: 1,014 Days
• Field of Search: None
• US Class Current: 514/327
• 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 starter pack for use in an initial dose escalation regimen which provides pirfenidone to a patient at a first oral daily dosage of 801 mg for days one to seven of the dose escalation regimen;

provides a second oral daily dosage of 1602 mg pirfenidone for days eight to fourteen of the dose escalation regimen; and

provides a third oral daily dosage of 2403 mg pirfenidone for at least day fifteen of the dose escalation regimen,

the starter pack comprising a plurality of compartments for containing a dosage amount of pirfenidone arranged within rows and columns,

wherein the starter pack comprises separate rows for Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14 with three separate columns for three dosage amounts to be taken each day; and

wherein each of the three compartments for Days 1, 2, 3, 4, 5, 6, and 7 separately contain one pill of 267-mg pirfenidone and each of the three compartments for Days 8, 9, 10, 11, 12, 13, and 14 separately contain two pills of 267-mg pirfenidone; and

wherein the starter pack optionally further comprises at least one additional set of compartments for Days 15, 16, 17, 18, 19, 20 and 21 in separate rows and each compartment in the additional set of compartments separately contain three pills of 267-mg pirfenidone.

2. The starter pack of claim 1, further comprising a first panel comprising the compartments for days 1, 2, 3, 4, 5, 6 and 7 and an additional panel for the compartments for days 8, 9, 10, 11, 12, 13, and 14.

3. The starter pack according to claim 1, wherein the compartments comprise blisters.

4. The starter pack according to claim 1, wherein the starter pack comprises at least two panels and at least one fold separating the two panels.

5. The starter pack of claim 1, further comprising a casing for holding several containers wherein each container comprises a panel bearing a set of compartments for Days 1, 2, 3, 4, 5, 6, and 7 or Days 8, 9, 10, 11, 12, 13, and 14, or one of the at least one additional set of compartments.

6. An initial dose escalation regimen method for providing pirfenidone therapy to a patient in need thereof, comprising:

administering pirfenidone to a patient at a first oral daily dosage of 801 mg for days one to seven of the dose escalation regimen;

administering a second oral daily dosage of 1602 mg pirfenidone for days eight to fourteen of the dose escalation regimen; and

administering a third oral daily dosage of 2403 mg pirfenidone for at least day fifteen of the dose escalation regimen, wherein the pirfenidone therapy is provided for a patient with a fibrosis condition.

7. The method of claim 6, wherein the fibrosis condition is selected from the group consisting of Hermansky-Pudlak Syndrome (HPS) associated pulmonary fibrosis and idiopathic pulmonary fibrosis (IPF).

8. The method of claim 6, further comprising instructing the patient to administer the dosage with food.

9. The method of claim 6, wherein each daily dosage is provided as a plurality of dosage forms comprising sub-daily dosages.

10. The method of claim 6, wherein each daily dosage is split into three divided doses provided three times a day.

11. The method of claim 6, wherein each oral daily dosage is provided in capsule form.

12. The method of claim 11, wherein each capsule comprises 267 mg of pirfenidone.