Methods and compositions to inhibit tolerance to opioids
Inventors
Iversen, Jacqueline • Dahl, Thomas A.
Assignees
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Publication Number
US-11129803-B2
Publication Date
2021-09-28
Expiration Date
Abstract
The present invention provides a method of inhibiting tolerance 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 inhibiting tolerance to an opioid in a human subject in need thereof during opioid therapy or during an opioid withdrawal period. A pharmaceutical composition is administered in which the active agents consist of a non-steroidal anti-inflammatory drug (NSAID) and a non-sedating antihistamine co-agent, including ibuprofen and co-agents such as ketotifen, fexofenadine, desloratadine, and cetirizine, including salts and combinations.
The core approach uses combinations of an NSAID with a specified co-agent to inhibit tolerance to an opioid, including during methadone detoxification. Oral unit-dose regimens and oral dosage forms such as tablets, lozenges, and chewing gum are described, including embodiments involving controlled or delayed release.
The document further states that the NSAID plus non-sedating antihistamine co-agent combination provides a synergistic reduction or absence of gastrointestinal adverse effects when used in the context of opioid therapy, including during methadone detoxification.
Claims Coverage
The partial claims provided include two independent claims, one during opioid therapy and one during an opioid withdrawal period. Both center on inhibiting opioid tolerance using a pharmaceutical composition whose active agents consist of an ibuprofen-based NSAID plus ketotifen or a salt thereof.
Inhibiting opioid tolerance during opioid therapy with ibuprofen and ketotifen
A method of inhibiting tolerance to an opioid by a human subject during opioid therapy by administering an effective amount of a pharmaceutical composition whose active agents consist of ibuprofen and a co-agent that is ketotifen or a salt thereof, wherein tolerance to an opioid is inhibited in the human subject.
Inhibiting opioid tolerance during an opioid withdrawal period with specified ibuprofen and ketotifen amounts
A method of inhibiting tolerance to an opioid by a human subject during an opioid withdrawal period by administering an effective amount of a pharmaceutical composition whose active agents consist of about 1200 mg to about 1600 mg of ibuprofen and about 0.5 mg to about 3 mg ketotifen, wherein tolerance to an opioid is inhibited in the human subject.
Across both independent claims, the claim scope is directed to inhibiting opioid tolerance in humans by administering an effective ibuprofen-containing NSAID formulation combined with ketotifen or ketotifen amounts as specified, with further dependent claim coverage narrowing dosage ranges and oral dosage forms.
Stated Advantages
Synergistic reduction or absence of gastrointestinal adverse effects when combining the NSAID with the co-agent.
Inhibition of tolerance to an opioid in the human subject.
Documented Applications
Inhibiting opioid tolerance in humans during opioid therapy.
Inhibiting opioid tolerance during an opioid withdrawal period.
Use during methadone detoxification.
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