Purdue Pharma L.p.

Euro-celtique S.a.

Robert D Colucci

Robert F Kaiko

Curtis Wright

Benjamin Oshlack

Christopher D Breder

Philip J Palermo

Ahmed El-Tahtawy

Raymond Sanchez

Stephen A Howard

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).

Opioid agonist/opioid antagonist/acetaminophen combinations

The present invention relates to, among other things, a kit comprising a plurality of dosage forms comprising a first dosage form and second dosage form each comprising a therapeutic agent, such as an opioid; wherein the dosage strength of the second dosage form is greater than that of the first dosage form; and wherein the steady state Cand the steady state AUC of the first and second dosage forms are dose proportional and the single dose Cof the second dosage form is less than the minimum level for dose proportionality with respect to the first dosage form. The present invention also relates to methods of administering such plurality of dosage forms to a patient, comprising administering the first dosage form and thereafter administering the second dosage form.

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The invention is directed in part to oral dosage forms comprising a combination of an orally analgesically effective amount of an opioid agonist 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).

Opioid agonist/antagonist combinations

The present invention relates to a plurality of dosage forms comprising a first dosage form and second dosage form each comprising a therapeutic agent, such as an opioid; wherein the dosage strength of the second dosage form is greater than that of the first dosage form; and wherein the steady state Cand the steady state AUC of the first and second dosage forms are dose proportional and the single dose Cof the second dosage form is less than the minimum level for dose proportionality with respect to the first dosage form. The present invention also relates to methods of administering such dosage forms to a patient, as well as to kits comprising such dosage forms and instructions for administration of the dosage forms to a patient. The inventors believe that the dosage forms and methods of the present invention will lead to improved safety and patient acceptance.

A titration dosing regimen for the administration of controlled release tramadol analgesic to patients. The titration dosing regimen provides a significant reduction in the occurrence of adverse effects from the introduction of controlled released tramadol dosing, thus increasing patient compliance and medication tolerability.

Titration dosing regimen for controlled release tramadol

Disclosed in certain embodiments is a pharmaceutical composition comprising from 10 to 40 mg of oxycodone or a pharmaceutically acceptable salt thereof and 0.65 to 0.90 mg naloxone or a pharmaceutically acceptable salt thereof.

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Newton, CT, United States of America

Robert D Colucci