Opioid agonist/opioid antagonist/acetaminophen combinations
OwnerRobert F. Kaiko, Robert D. Colucciinventors
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Abstract
The invention is directed in part to oral dosage forms comprising a combination of an opioid agonist, acetaminophen and an orally active opioid antagonist, the opioid antagonist being included in a ratio to the opioid agonist to provide a combination product which is analgesically effective when the combination is administered orally, but which is aversive in a physically dependent subject. Preferably, the amount of opioid antagonist included in the combination product provides at least a mildly negative, “aversive” experience in physically dependent addicts (e.g., precipitated abstinence syndrome).
Claims36
An oral dosage form, comprising
- (A) an opioid agonist;
- (B) acetaminophen, and
- (C) an opioid antagonist, the ratio of opioid antagonist to opioid agonist to acetaminophen providing a combination product which is analgesically effective when the combination is administered orally, but which is aversive in physically dependent human subjects when administered at the same dose or at a higher dose than the usually prescribed dose of the opioid agonist.
A method of treating pain, comprising administering an oral dosage form which contains an opioid agonist and acetaminophen in amounts which render the dosage form analgesically effective when orally administered, the oral dosage form further including an opioid antagonist in a ratio to said opioid agonist such that the oral dosage form is analgesically effective when administered orally, but is aversive in physically dependent human subjects when administered at the same dose or at a higher dose than the usually prescribed dose of the opioid agonist.
Dependencies are inferred from the claim text.