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Morphine/naltrexone.

Sean T Duggan1, Lesley J Scott

  • 1Adis, Auckland, New Zealand. demail@adis.co.nz

CNS Drugs
|May 7, 2010
PubMed
Summary
This summary is machine-generated.

Oral morphine/naltrexone extended-release capsules effectively manage moderate to severe chronic pain, including osteoarthritis. This formulation combines sustained-release morphine with an abuse-deterrent naltrexone component for improved patient outcomes.

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Area of Science:

  • Pharmacology
  • Pain Management
  • Drug Delivery Systems

Background:

  • Chronic pain, including osteoarthritis, significantly impacts quality of life.
  • Existing opioid formulations present challenges related to misuse and abuse.
  • There is a need for effective pain management strategies with abuse-deterrent properties.

Purpose of the Study:

  • To evaluate the efficacy and safety of oral morphine/naltrexone extended-release capsules for moderate to severe chronic pain.
  • To assess the abuse-deterrent properties of the morphine/naltrexone formulation.
  • To compare the efficacy of morphine/naltrexone against placebo in patients with osteoarthritis.

Main Methods:

  • A randomized, double-blind, placebo-controlled, phase III study (n=344) evaluated efficacy in osteoarthritis pain.
  • A 12-month open-label safety study (n=465) assessed long-term pain control and tolerability in nonmalignant pain.
  • Brief Pain Inventory (BPI) scores were used to measure pain severity.

Main Results:

  • Morphine/naltrexone demonstrated significant improvement in Brief Pain Inventory (BPI) average pain scores compared to placebo over 12 weeks in osteoarthritis patients.
  • The formulation provided effective pain relief and sustained pain control in patients with chronic nonmalignant pain over 12 months.
  • Treatment was generally well tolerated in adult patients across clinical trials.

Conclusions:

  • Oral morphine/naltrexone extended-release capsules are effective for managing moderate to severe chronic pain, including osteoarthritis.
  • The formulation offers sustained pain relief and is generally well-tolerated.
  • The abuse-deterrent design mitigates the effects of tampering, addressing a key concern with opioid therapy.