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

a technology for respiratory illness and opioids, applied in the direction of drug compositions, biocide, heterocyclic compound active ingredients, etc., can solve the problems of increased carbon dioxide retention, respiratory depression, and morphine-related opioids, and achieve the effect of minimizing the risk of developing sleep

Inactive Publication Date: 2005-03-10
QRXPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0025] In yet another embodiment, the present invention provides 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 cons...

Problems solved by technology

In addition to potent analgesic effects, the morphine-related opioids may also cause a number of undesirable effects, including, for example, nausea, vomiting, dizziness, mental clouding, dysphoria, pruritus, constipation, increased biliary tract pressure, urinary retention, hypotension and, most notably, respiratory depression.
Respiratory depression becomes significant when it leads to the need for medical intervention.
Opioids interfere with carbon dioxide chemoreceptors in the medulla leading to increased retention of carbon dioxide.
Naloxone will immediately reverse opioid-induced respiratory depression, but the dose may have to be repeated due to the short duration of action of naloxone.
More importantly, naloxone will also antagonise the analgesic effect, thus negating the primary clinical purpose of administration of the opioid.
Patients with compromised lungs (i.e., with respiratory illnesses) are at increased risk for opiate induced respiratory depression and/or cessation because of their impaired respiratory capability.
For example, a burn dressing change or a bone marrow aspiration may be intensely painful for only a brief time.
However, excessive sedation and respiratory depression may occur following the procedure when respiratory stimulation declines along with a rapid reduction in the intensity of pain and distress.
While depression of ventilatory responses to hypoxemia is of little consequence to most healthy subjects, the consequences can be severe in patients who may be dependent on hypoxic respiratory drive, such as those with chronic obstructive pulmonary disease (COPD) and long-standing hypercapnia.
Also, certain disease states may increase respiratory risks from the administration of opioids.
Morbidly obese and Pickwickian patients may have difficulties with opioid dose titration.
It has also been noted that abdominal surgery is associated with postoperative sleep disturbance.
The primary causes of upper airway obstruction are lack of muscle ...

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0060] Effects of Combined Morphine / Oxycodone Formulations on Respiration

[0061] Objective The main objective was to compare the ventilatory responses to hypoxia and hypercarbia following one hour intravenous infusions of (1) morphine 15 mg, or (2) oxycodone 15 mg, or (3) morphine 10 mg+oxycodone 5 mg, or (4) oxycodone 10 mg+morphine 5 mg, or (5) morphine 7.5 mg+oxycodone 7.5 mg. Each infusion was administered over 1 h and was designated by its respective composition as M15, M10_O5, M7.5_O7.5, M5_O10 or O15.

[0062] Design A triple blind placebo-controlled, 5-period, randomised crossover study in 10 males was conducted. On each of the 5 study days for each of the 10 subjects, there was a baseline period, followed by either a 1 h drug or “placebo” i.v. infusion, followed by 1 h “placebo” or drug infusion, followed by a 1 h “washout”. Serial measures of drug effect were accompanied by serial peripheral venous blood sampling. The hypoxemic and hypercapnic ventilatory responses were dete...

example 2

[0066] Analgesia in Patients using Sub-analgesic Combinations of Morphine & Oxycodone in a Ratio of 1:0.66 by Weight

[0067] Objective: to determine the dose of a taste masked oral syrup of morphine and oxycodone in a ratio of 1:0.66 by weight compared to a taste masked syrup containing morphine alone.

[0068] Design A triple-blind (patient, investigator and analyst) randomized, controlled, two-period cross-over study was designed to assess the effectiveness of morphine compared to an oxycodone and morphine mixture. The study was carried out in 21 patients with chronic non-cancer pain. The morphine was formulated to a solution concentration of 5 mg / mL and the combination formulation to a concentration of morphine 1.5 mg / mL and oxycodone 1 mg / mL. The solution strengths were determined so that the expected total dose per day in mL would be similar between the two treatments thereby retaining blinding. Each opioid solution was administered every 4 hours with the 10 pm and 2 am doses bein...

example 3

[0071] Analgesia in Patients using Sub-analgesic Combinations of Morphine & Oxycodeone in a Ratio of 1:2.0 by Weight

[0072] Objective: to determine the dose of a taste masked oral syrup of morphine and oxycodeone in a ratio of 1:2.0 by weight compared to a taste masked syrup containing morphine alone.

[0073] Design & Analysis: a similar design and analysis to that used in Example 1 was followed.

[0074] Results: Analgesic Effects As with Example 2, no significant differences in VAS scores were noted between any of the treatment groups. The effective dose of the 1:2.0 combination versus morphine required to provide analgesia is shown in Table 2. The results show a weight of the combined product to weight or morphine to be 46%. The results was statistically significant (P<0.002).

TABLE 2Comparison of doses required for stabilized pain control.Dose, mgTreatmentPatients(by weight)Morphine2268Combination of2155morphine tooxycodone1:2.0(Morphine +46%Oxycodonedose) / Morphinedose

[0075] In s...

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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.

Description

FIELD OF THE INVENTION [0001] The technical field of the invention relates to the use of sub-analgesic doses of opioids for the treatment of pain in patients with a diagnosed or undiagnosed respiratory illness or respiratory disorder. BACKGROUND OF THE INVENTION [0002] When a patient experiences significant pain as the result of a serious traumatic injury, a surgical procedure, or chronic illness (e.g., cancer), relief requires strong medication under a doctor's prescription. Opiate drugs are a class of pain-relieving prescription drugs frequently prescribed for moderate to severe pain. The opioids are a group of drugs, both natural and synthetic, that are employed primarily as centrally-acting analgesics and are opium or morphine-like in their properties (Gilman et al., 1980, GOODMAN AND GILMAN'S THE PHARMACOLOGICAL BASIS OF THERAPEUTICS, Chapter 24:494-534, Pergamon Press; hereby incorporated by reference). The opioids include morphine and morphine-like homologs, including, e.g., ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/445A61K31/485A61K45/06A61P11/00A61P25/04
CPCA61K31/445A61K31/485A61K45/06A61K2300/00A61P11/00A61P11/06A61P25/04A61P25/20A61P35/00A61P43/00
Inventor PACE, GARY W.SMITH, MAREE T.
Owner QRXPHARMA
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