Methods for the treatment of back pain
First Claim
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1. A method for treating back pain in a human subject comprising administering to the subject an opioid agonist and an opioid antagonist, wherein back pain is alleviated and wherein the amount of the antagonist is effective to attenuate withdrawal.
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Abstract
Methods and materials, including novel compositions, dosage forms and methods of administration, useful for treating back pain using opioid antagonists, including combinations of opioid antagonists and opioid agonists. Methods and materials comprising opioid antagonists or combinations opioid antagonists and agonists may optionally include one or more additional therapeutic agents.
122 Citations
110 Claims
- 1. A method for treating back pain in a human subject comprising administering to the subject an opioid agonist and an opioid antagonist, wherein back pain is alleviated and wherein the amount of the antagonist is effective to attenuate withdrawal.
- 7. A method for treating back pain in a human subject comprising administering to the subject an opioid agonist and an opioid antagonist, wherein back pain is alleviated and wherein the amount of the antagonist is effective to attenuate one or more opioid-related adverse effects.
- 10. A method for treating back pain in a human subject comprising administering to the subject an opioid agonist and an opioid antagonist, wherein back pain is alleviated and wherein the amount of the antagonist is effective to attenuate one or more adverse effects of dependence, tolerance, or addiction.
- 58. A method for treating back pain in a human subject being administered an opioid agonist, the method comprising administering to the subject an opioid antagonist, wherein back pain is alleviated, and wherein the amount of the antagonist is effective to attenuate withdrawal.
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59. A method for treating back pain in a human subject being administered an opioid agonist, the method comprising administering to the subject an opioid antagonist, wherein back pain is alleviated, and wherein the amount of the antagonist is effective to attenuate one or more opioid-related adverse effects.
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60. A method for treating back pain in a human subject being administered an opioid agonist, the method comprising administering to the subject an opioid antagonist, wherein back pain is alleviated, and wherein the amount of the antagonist is effective to attenuate one or more adverse effects of dependence, tolerance, or addiction.
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64. A method of dosing an opioid antagonist administered to a human subject having back pain, the method comprising the steps of:
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(a) administering an amount of an opioid antagonist and an amount of an opioid agonist to the subject;
(b) assessing back pain;
(c) measuring a level of the opioid antagonist or a surrogate of the opioid antagonist in a sample from the subject; and
(d) adjusting the amount of the opioid antagonist or the amount of the opioid agonist to the subject based on the measured level. - View Dependent Claims (65, 66, 67, 68, 69, 70, 71, 72, 73)
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74. A method of dosing an opioid antagonist to a human subject having back pain, the method comprising the steps of:
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(a) administering an amount of an opioid antagonist and an amount of an opioid agonist to the subject;
(b) assessing back pain; and
(c) adjusting the amount of the opioid antagonist administered to the subject the back pain is not alleviated to a desired extent. - View Dependent Claims (75, 76, 77, 78, 79, 80, 81, 82, 83)
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84. A method of dosing an opioid antagonist to a human subject, the method comprising the steps of:
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(a) administering an amount of an opioid antagonist and an amount of an opioid agonist to the subject;
(b) measuring a level of the opioid antagonist or a surrogate of the opioid antagonist in a sample from the subject; and
(c) adjusting the amount of the opioid antagonist administered to the subject if the measured level is outside a predetermined range. - View Dependent Claims (85, 86, 87, 88)
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89. A method of determining the amount of an opioid antagonist or opioid agonist to be administered to a human subject having back pain, the method comprising the steps of:
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(a) assessing back pain in a human subject being administered an opioid antagonist and an opioid agonist;
(b) measuring a level of the opioid antagonist or a surrogate of the opioid antagonist in a sample obtained from the human subject;
(c) on the basis of the measured level, adjusting the amount of the opioid antagonist or the amount of the opioid agonist for administration to the human subject. - View Dependent Claims (90, 91, 92)
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- 93. A method of reducing the level of a biomarker in a human subject having back pain, comprising administering to the subject a composition comprising an opioid antagonist and optionally an opioid agonist.
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101. A method to monitor the response of a human subject being treated for back pain, by administering an opioid antagonist, comprising the steps of:
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(a) determining the level of one or more one biomarker(s) in a first sample from the subject prior to treatment with the opioid antagonist;
(b) determining the level of the biomarker in at least a second sample from the subject subsequent to the initial treatment with the opioid antagonist; and
(c) comparing the level of the biomarker in the second sample with the level of the biomarker in the first sample;
wherein a change in the level of the biomarker in the second sample compared to the level of the biomarker in the first sample indicates the effectiveness of the treatment. - View Dependent Claims (103, 104, 105, 106, 107, 108, 109, 110)
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102. A method to monitor the response of a human subject being treated for back pain, by administering an opioid antagonist and an opioid agonist, comprising the steps of:
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(a) determining the level of one or more one biomarker(s) in a first sample from the subject prior to treatment with the opioid antagonist and the opioid agonist;
(b) determining the level of the biomarker in at least a second sample from the subject subsequent to the initial treatment with the opioid antagonist and the opioid agonist; and
(c) comparing the level of the biomarker in the second sample with the level of the biomarker in the first sample;
wherein a change in the level of the biomarker in the second sample compared to the level of the biomarker in the first sample indicates the effectiveness of the treatment.
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Specification