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Oxycodone/Naloxone Prolonged Release: A Review in Severe Chronic Pain
1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. demail@springer.com.
Clinical Drug Investigation
|November 4, 2017
Summary
Oral oxycodone/naloxone prolonged release (PR) effectively manages severe pain and opioid-induced constipation (OIC). This fixed-dose combination offers sustained pain relief and improved bowel function in chronic pain patients.
Area of Science:
- Pharmacology
- Gastroenterology
- Pain Management
Background:
- Severe pain necessitates effective analgesia, often requiring opioid therapy.
- Opioid-induced constipation (OIC) is a common and distressing side effect of opioid analgesics.
- Managing OIC is crucial for patient adherence and quality of life.
Purpose of the Study:
- To evaluate the efficacy and safety of oral oxycodone/naloxone prolonged release (PR) in adults with severe chronic pain and OIC.
- To assess the impact of naloxone on opioid-induced constipation.
- To compare the analgesic efficacy of oxycodone/naloxone PR with oxycodone PR.
Main Methods:
- Short-term (5-12 week) and long-term (24-52 week) clinical trials were conducted.
- Participants included adults with moderate to severe chronic pain and OIC.
- Efficacy endpoints included pain management and improvement in OIC; safety was also assessed.
Main Results:
- Oxycodone/naloxone PR demonstrated significant improvement in OIC compared to oxycodone PR.
- Analgesia provided by oxycodone/naloxone PR was noninferior to oxycodone PR.
- Improvements in pain and bowel function were sustained in long-term studies.
- Real-world data corroborated clinical trial findings.
Conclusions:
- Oral oxycodone/naloxone PR is an effective treatment for severe chronic pain in adults.
- The addition of naloxone effectively counteracts opioid-induced constipation.
- Oxycodone/naloxone PR offers a valuable therapeutic option for patients with OIC.
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