Methods useful for the treatment of pain, arthritic conditions or inflammation associated with a chronic condition

Abstract

Methods, including those for administering novel pharmaceutical compositions, dosage forms containing an opioid active pharmaceutical ingredient, are useful for treating pain, arthritic conditions and / or inflammation associated with a chronic condition, including pain from arthritis and inflammation.

Description

FIELD OF THE INVENTION[0001]The present invention relates to methods, including novel methods of administration, useful for the treatment of pain, arthritic conditions, and / or inflammation associated with a chronic condition, using opioid compositions. The methods provide human subjects with an alleviation of one or more symptoms or signs of pain, an arthritic condition or inflammation associated with a chronic condition, including, for example, reduced pain, reduced stiffness and / or improved physical function.BACKGROUND OF THE INVENTION[0002]Opioids are a broad class of drugs used clinically in the management of pain, but their use is limited by a constellation of undesirable side effects, including their potential for dependence and abuse. The principle actions and therapeutic value of opioids are analgesia and sedation. The precise mechanisms of action for these effects are unknown; however, specific central nervous system opioid receptors for endogenous compounds with opioid-lik...

AI Technical Summary

Benefits of technology

[0012]In some embodiments, the chronic pain is associated with a joint, hip, knee, back, neck, or lower back of the subject. In some embodiments, the pain is measured as pain intensity. In some embodiments, the pain intensity is attenuated as compared to a pain intensity baseline of the subject. In some embodiments the pain is measured on the pain subscale of the WOMAC Osteoarthritis Index. In some embodiments, the pain measurement of the subject is improved with administration of the opioid as compared to baseline pain measurement of the subject on the WOMAC pain subscale baseline of the subject.

[0027]Advantages of methods of the invention include enhanced and prolonged analgesia, prevention of tolerance and continued protection against tolerance even with chronic administration, reversal of opioid-induced hyperalgesia, prevention of physical dependence or withdrawal, decreased rewarding / euphoric side effect, and / or decreased potential for relapse / addiction.

Problems solved by technology

Opioids are a broad class of drugs used clinically in the management of pain, but their use is limited by a constellation of undesirable side effects, including their potential for dependence and abuse.

However, marketed versions of controlled-release oxycodone have been the subject of intense media scrutiny due to an epidemic of misuse, abuse and diversion.

Abusers can easily disrupt the controlled-release mechanism of OxyContin by crushing, chewing or dissolving tablets or capsules in alcohol, leading to an immediate surge in oxycodone blood levels, which can produce a sense of euphoria but can also lead to respiratory depression and even death.

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