Methods and compositions to inhibit dependence on opioids
Inventors
Iversen, Jacqueline M. • Dahl, Thomas A.
Assignees
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Publication Number
US-10675261-B2
Publication Date
2020-06-09
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 of inhibiting dependence to an opioid by a human subject in need thereof during opioid therapy. The method comprises administering an effective amount of a pharmaceutical composition during opioid therapy, where dependence to an opioid is inhibited in the human subject.
The pharmaceutical composition includes a non-steroidal anti-inflammatory drug (NSAID) and a co-agent selected from fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof, and combinations thereof. The document further describes example combinations that pair an NSAID such as ibuprofen or aspirin with one of the specified co-agents, including fexofenadine and ketotifen.
The disclosed embodiments provide pharmaceutical compositions and dosage forms for the co-agent and NSAID, including one unit dose and oral dosage forms such as tablet, lozenge, and chewing gum, and embodiments involving controlled release or delayed release. The combination is administered during opioid therapy to inhibit opioid-dependence and withdrawal-related symptoms.
Claims Coverage
The document contains two independent claims. Both focus on inhibiting dependence to an opioid during opioid therapy by administering an NSAID together with a specified co-agent, with the opioid selected from a defined list; the second independent claim further limits the composition to essentially ibuprofen plus ketotifen in specified amounts.
Inhibiting opioid dependence using an NSAID plus a co-agent during opioid therapy
A method of inhibiting dependence to an opioid by administering an effective amount of a pharmaceutical composition to a human subject during opioid therapy, the composition comprising an NSAID and a co-agent selected from fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof, wherein dependence to an opioid is inhibited; the opioid is selected from opium, heroin, morphine, codeine, thebaine, hydrocodone, oxycodone, fentanyl, methadone, pethidine and hydromorphone.
Inhibiting opioid dependence with an ibuprofen and ketotifen composition consisting essentially of specified amounts
A method of inhibiting dependence to an opioid by administering an effective amount of a pharmaceutical composition during opioid therapy, wherein the pharmaceutical composition consists essentially of 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, and the opioid is selected from opium, heroin, morphine, codeine, thebaine, hydrocodone, oxycodone, fentanyl, methadone, pethidine and hydromorphone.
Across the independent claims, the inventive coverage centers on administering an NSAID together with a specified co-agent during opioid therapy to inhibit dependence to a selected opioid; one independent claim broadly covers the NSAID plus one of several listed co-agents, while the other independent claim restricts the composition to essentially ibuprofen plus ketotifen within specified amounts.
Stated Advantages
Inhibition of dependence to an opioid in a human subject during opioid therapy.
Synergistic inhibition of withdrawal-related symptoms.
Unexpected reduction of gastrointestinal adverse effects.
Documented Applications
Methods for inhibiting physical dependence/withdrawal during opioid therapy by administering an NSAID plus a non-sedating antihistamine co-agent to reduce dependence and withdrawal-related symptoms.
Embodiments relevant to opioid dependence/withdrawal contexts including opioid dependence and withdrawal syndrome during opioid therapy.
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