Methods and compositions for reducing the risk associated with the administration of opioid analgesics in patients with diagnosed or undiagnosed respiratory illness

• US 20050053659A1
• Filed: 09/10/2003
• Published: 03/10/2005
• Est. Priority Date: 09/10/2003
• Status: Abandoned Application

• Current Assignee: Qrxpharma Ltd.
• Original Assignee: Gary W. Pace, Maree T. Smith
• Inventors: Smith, Maree T., Pace, Gary W.
• Application Number:
  US10/661,458
• Publication Number:
  US 20050053659A1
• Time in Patent Office: Days
• US Class Current: 424/468
• 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 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to methods for reducing the risk associated with the administration of opioid analgesics in patients diagnosed or undiagnosed with respiratory illness by administering an analgesic composition comprising a sub-analgesic dosage of a μ-opioid agonist selected from the group consisting of morphine, fentanyl, sufentanil, alfentanil, oxymorphone and hydromorphone, or a pharmaceutically acceptable salt thereof, and a sub-analgesic dosage of oxycodone which is a κ₂-opioid agonist or a pharmaceutically acceptable salt thereof.

Claims

1. A method for reducing the risk associated with the administration of opioid analgesics in patients with diagnosed or undiagnosed respiratory illness, or at risk for same, by administering an analgesic composition comprising a sub-analgesic dosage of a μ

-opioid agonist selected from the group consisting of morphine, fentanyl, sufentanil, alfentanil, oxymorphone and hydromorphone, or a pharmaceutically acceptable salt thereof, and a sub-analgesic dosage of oxycodone, a κ

₂-opioid agonist, or a pharmaceutically acceptable salt thereof, wherein the method achieves an analgesic effect in the patient to which the composition is administered.

2. The method of claim 1, wherein the μ

-opioid agonist is in the form of a pharmaceutically acceptable salt.

3. The method of claim 1, wherein the μ

-opioid agonist is morphine.

4. The method of claim 1, wherein the μ

-opioid agonist is fentanyl.

5. The method of claim 1, wherein the μ

-opioid agonist is hydromorphone.

6. The method of claim 1, wherein the μ

-opioid agonist is oxymorphone.

7. The method of claim 1 wherein the oxycodone is in the form of a pharmaceutically acceptable salt.

8. The method of claim 3, wherein the combined mass of morphine and oxycodone is about 50% of the mass of morphine alone required to achieve the same analgesic effect in the patient to which the composition is administered.

9. The method of claim 3, wherein the combined mass of morphine and oxycodone is about 75% of the mass of oxycodone alone required to achieve the same analgesic effect in the patient to which the composition is administered.

10. The method of claim 1, wherein the composition is administered in an immediate release oral dosage form.

11. The method of claim 1, wherein the composition is administered in a sustained release oral dosage form.

12. The method of claim 1, wherein the composition is administered through a subcutaneous, intravenous, intramuscular, epidural, transdermal, inhalation, buccal or sublingual route.

13. The method of claim 1, wherein the respiratory illness is selected from the group consisting of asthma, bronchiectasis, pulmonary tuberculosis, chronic obstructive pulmonary disease, bronchitis, bronchopneumonia, chronic laryngitis, chronic sinusitis, emphysema, fibrosing alveolitis, idiopathic pulmonary fibrosis and sarcoidosis.

14. The method of claim 1, wherein the respiratory illness is cancer.

15. The method of claim 14, wherein the cancer is lung cancer.

16. The method of claim 14, wherein the cancer is selected from the group consisting of non-small cell lung cancer, adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma, small cell lung cancer, oat cell cancer and mesothelioma.

17. The method of claim 1, wherein the respiratory illness is a respiratory sleep disorder.

18. The method of claim 17, wherein the respiratory sleep disorder is sleep apnea.

19. The method of claim 18, wherein the sleep apnea is selected from the group consisting of central sleep apnea, obstructive sleep apnea and mixed sleep apnea.

20. A method of minimizing the risk of developing sleep apnea in susceptible patients treated for the alleviation or prevention of pain, wherein the method comprises the step of administering an analgesic composition comprising a sub-analgesic dosage of a μ

-opioid agonist selected from the group consisting of morphine, fentanyl, sufentanil, alfentanil, oxymorphone and hydromorphone, or a pharmaceutically acceptable salt thereof, and a sub-analgesic dosage of oxycodone, a κ

₂-opioid agonist, or a pharmaceutically acceptable salt thereof.

21. The method of claim 20, wherein the sleep apnea is selected from the group consisting of central sleep apnea, obstructive sleep apnea and mixed sleep apnea.

22. An analgesic composition comprising a sub-analgesic dosage of morphine, a μ

-opioid agonist, and a sub-analgesic dosage of oxycodone, a κ

₂-opioid agonist, or pharmaceutically acceptable salts thereof, wherein the composition, upon administration to a patient, achieves an analgesic effect in that patient, equivalent to the analgesic effect that would result from the administration of an analgesic composition consisting of about twice the mass of morphine alone.

23. An analgesic composition comprising a sub-analgesic dosage of morphine, a μ

-opioid agonist, and a sub-analgesic dosage of oxycodone, a κ

₂-opioid agonist, or pharmaceutically acceptable salts thereof, wherein the composition, upon administration to a patient, achieves an analgesic effect in that patient equivalent to the analgesic effect that would result from the administration of an analgesic composition consisting of about 1.5 times the mass of oxycodone alone.