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

a technology of chronic conditions and pain, applied in the direction of heterocyclic compound active ingredients, biocide, drug compositions, etc., can solve the problems of oxycodone marketed versions, limited use, dependence and abuse,

Inactive Publication Date: 2009-12-03
DURECT CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides methods for treating pain, arthritic conditions, and inflammation using an oral opioid pharmaceutical composition. The methods involve administering the composition to a subject in need of treatment. The composition comprises an opioid active pharmaceutical ingredient (API), a sucrose acetate isobutyrate liquid carrier material, triacetin, isopropyl myristate, cellulose acetate butyrate, hydroxyethyl cellulose, colloidal silicon dioxide, and butylated hydroxytoluene. The methods provide effective treatment for pain, arthritic conditions, and inflammation associated with a chronic condition. The opioid can be in the form of a free base or a salt. The methods can be used in humans and the pain can be measured using various methods such as pain intensity or the WOMAC pain subscale. The invention provides a novel pharmaceutical composition for the treatment of pain, arthritic conditions, and inflammation.

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.

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

example 1

Evaluation of the Efficacy and Safety of an Oral Opioid Pharmaceutical Composition

[0268]A clinical trial of an exemplary oral opioid pharmaceutical composition was conducted as follows. The “study drug” used in the clinical trial is a controlled release oral formulation containing oxycodone as the API. The clinical trial was conducted in subjects with moderate to severe chronic pain due to osteoarthritis of the hip or knee. A primary objective of the clinical trial was to study the efficacy and safety of the study drug in these subjects. A secondary objective of the clinical trial was to compare quality of life measures in these subjects with moderate to severe chronic pain due to osteoarthritis of the hip or knee who receive the study drug as compared with those who receive placebo.

[0269]For this clinical trial, a multicenter, randomized, double-blind, placebo-controlled, phase III study was conducted in approximately four hundred subjects with moderate to severe chronic pain due t...

example 2

Preparation of Opioid Formulations

[0532]Exemplary opioid dosage forms comprising oxycodone are prepared as described herein. For clinical studies as described in Example 1, capsules having different amounts of oxycodone are produced.

[0533]Capsule formulations containing oxycodone at various dose levels (5.0, 10.0, 20.0, 30.0 and 40.0 mg / capsule) and matching placebo capsules are prepared.

[0534]The components, pharmaceutical grade, and function of each component used to make oxycodone capsules are provided in Table 16 below.

TABLE 16Components for Oxycodone CapsulesComponentFunctionOxycodone base (micronized)Active pharmaceutical ingredientSucrose acetate isobutyrateLiquid carrier materialTriacetin, USPSolventIsopropyl myristate, NFRheology modifierCellulose acetate butyrate, NF / EP,Network formerethanol washed (grade 381-20 BP)Hydroxyethyl cellulose, NFHydrophilic agentColloidal silicon dioxide, NFViscosity enhancing agentButylated hydroxytoluene, NFAntioxidantHard gelatin capsuleDosa...

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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...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/4355A61K31/34
CPCA61K9/4858A61K9/4866A61K9/48A61K31/4402A61K31/485A61K31/137A61K31/4458A61P19/00A61P19/02A61P25/00A61P25/04A61P25/20A61P25/24A61P25/26A61P25/36A61P29/00A61P35/00A61P43/00
Inventor YUM, SU ILCHAO, WENDYFU, ROGERZAMLOOT, MICHAEL
Owner DURECT CORP
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