Methods and compositions to inhibit dependence on opioids
Inventors
Iversen, Jacqueline M. • Dahl, Thomas A.
Assignees
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Publication Number
US-12280028-B2
Publication Date
2025-04-22
Expiration Date
Abstract
The present invention provides a method of inhibiting dependence to an opioid by a human subject in need thereof. The method comprises administering an effective amount of a pharmaceutical composition to the subject during opioid therapy. The pharmaceutical composition comprises a) a non-steroidal anti-inflammatory drug (NSAID); and b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof.
Core Innovation
The invention relates to methods and pharmaceutical compositions for inhibiting physical opioid dependence in a human subject during opioid therapy. The approach administers an NSAID together with a non-sedating co-agent selected from fexofenadine, ketotifen, desloratadine, or cetirizine, including salts thereof and combinations thereof.
Physical opioid dependence is addressed by reducing the severity and/or duration of opioid withdrawal syndrome. Inhibition is assessed by reduced severity and/or reduced duration of withdrawal, and the composition is provided in unit-dose and dosage-form concepts such as tablets, lozenges, chewing gum, orally dissolving tablet, and controlled release forms.
The disclosed compositions include NSAID examples such as ibuprofen and aspirin, as well as other NSAIDs, and the co-agent is combined with the NSAID as a selected co-agent. The document asserts unexpectedly slight or absent NSAID-related GI adverse effects due to synergy between the NSAID and the co-agent, supporting use of the combination during opioid therapy, including methadone detoxification therapy.
Claims Coverage
The document includes two independent claims that cover methods for inhibiting dependence to an opioid during opioid therapy using an NSAID and a specified non-sedating co-agent, with the second independent claim further constraining the ibuprofen/ketotifen amounts.
Inhibiting opioid dependence with NSAID and selected non-sedating co-agent
Administering an effective amount of a pharmaceutical composition during opioid therapy, wherein the composition comprises an NSAID and a co-agent selected from fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof, wherein dependence to an opioid is inhibited in the human subject.
Inhibiting opioid dependence with ibuprofen/ketotifen composition
Administering an effective amount of a pharmaceutical composition during an opioid therapy, wherein the pharmaceutical composition consists of active agents: about 1200 mg to about 1600 mg of ibuprofen and about 0.5 mg to about 3 mg ketotifen, wherein dependence to an opioid is inhibited in the human subject.
Across the independent claims, opioid dependence is inhibited by administering an NSAID plus a non-sedating co-agent (selected from fexofenadine, ketotifen, desloratadine, cetirizine, including salts and combinations), or by administering a composition consisting of specified ibuprofen and ketotifen amounts.
Stated Advantages
Inhibition of dependence to an opioid in a human subject during opioid therapy.
Reduced severity and/or reduced duration of opioid withdrawal syndrome.
Unexpectedly slight or absent NSAID-related GI adverse effects due to synergy with the non-sedating co-agent.
Documented Applications
Use during opioid therapy to inhibit physical opioid dependence and reduce opioid withdrawal syndrome.
Use during methadone detoxification therapy.
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