EXTENDED RELEASE HYDROCODONE ACETAMINOPHEN AND RELATED METHODS AND USES THEREOF

• US 20100010030A1
• Filed: 02/04/2009
• Published: 01/14/2010
• Est. Priority Date: 02/01/2008
• Status: Active Grant

• Current Assignee: Abbvie Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Jain, Rita I., Vo, Pamela Giang, Lockhart, Earle, Marx, Steven E., Thomas, James W., Best, Andrea E.
• Granted Patent: US 9,226,907 B2
• Time in Patent Office: Days
• US Class Current: 514/282
• 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 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/439 the ring forming part of a bridged ring system, e.g. quinuclidine 8-azabicyclo [3.2.1] octanes A61K31/46
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• 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 present invention generally provides a method of treatment and improvement of quality of life for patients adversely affected by various pain conditions. One preferred embodiment provides a method of treatment of acute pain, moderate to moderately severe pain, chronic pain, non-cancer pain, osteoarthritic pain, bunionectomy pain or lower back pain in a patient in need thereof, comprising providing at least one or two dosage form having about 15 mg of hydrocodone and its salt and about 500 mg of acetaminophen, once, twice or thrice daily. Preferably, the dosage form is about 30 mg of hydrocodone and about 1000 mg of acetaminophen taken twice daily. Alternatively, the dosage form is about 15 mg of hydrocodone and about 500 mg of acetaminophen taken twice daily.

Claims

1. A method of treatment of acute pain, moderate to moderately severe pain, chronic pain, non-cancer pain, osteoarthritic pain, bunionectomy pain or lower back pain in a patient in need thereof comprises providing at least one or two dosage form comprising about 15 mg of hydrocodone and its salt and about 500 mg of acetaminophen, once, twice or thrice daily.

2. The method according to claim 1, where the dosage form is about 30 mg of hydrocodone and about 1000 mg of acetaminophen taken twice daily.

3. The method according to claim 1, wherein the dosage form is about 15 mg of hydrocodone and about 500 mg of acetaminophen taken twice daily.

4. The method according to claim 1, wherein said dosage form may be taken by the patient with or without food.

5. The method of according to claim 1, wherein co-administration of about 240 ml of 40%, 20%, 4% and 0% ethanol on the single dosage form affects the mean maximum plasma concentration level Cmax by ≦

25% for both hydrocodone and acetaminophen in the patient.

6. The method according to claim 1, wherein Cmax and AUC of hydrocodone for a patient with mild to moderately impaired hepatic function is substantially similar to the normal patient and wherein Cmax and AUC of acetaminophen for a patient with mildly impaired hepatic function is substantially similar to the normal patient.

7. The method according to claim 1, wherein no overall statistical differences in effectiveness is observed for the patient metabolizing hydrocodone when the patient is a poor or competent metabolizer of Cytochrome P450 2D6 polymorphism.

11. The method of any one of the claims 1, 4, 5, 6, 7, 8 and 9, wherein the dosage form comprises about 15 mg of hydrocodone or a therapeutically acceptable salt thereof and about 500 mg of acetaminophen.

12. The method of any one of the claims 1, 4, 5, 6, 7, 8 and 9, wherein the dosage form comprises about 30 mg of hydrocodone or a therapeutically acceptable salt thereof and about 1000 mg of acetaminophen.

8. A method of improving quality of life in a patient in need thereof, comprising administering to said patient a controlled release twice daily dosage form including acetaminophen and hydrocodone or a therapeutically effective salt thereof.

10. The method of any one of the claims 8 and 9, wherein the dosage form comprises about 15 mg of hydrocodone or a therapeutically acceptable salt thereof and about 500 mg of acetaminophen.

9. A method of reducing loss of productivity in a patient having pain related condition, comprising administering to said patient a controlled release twice daily dosage form including acetaminophen and hydrocodone or a therapeutically effective salt thereof.