Compositions Comprising An Opioid And An Additional Active Pharmaceutical Ingredient For Rapid Onset And Extended Duration Of Analgesia That May Be Administered Without Regard To Food

A solid oral dosage form comprising:

• (a) at least one immediate release portion comprising acetaminophen and oxycodone or a pharmaceutically acceptable salt thereof;
• and
• (b) at least one extended release portion comprising acetaminophen, oxycodone or a pharmaceutically acceptable salt thereof, and an extended release component;
• wherein the total amount of acetaminophen in the dosage form is about 325 mg to about 650 mg, and the total amount of oxycodone or its pharmaceutically acceptable salt in the dosage form is about 5 mg to about 15 mg;
• and
• wherein upon oral administration of the dosage form to a subject, the dosage form provides an abuse quotient for oxycodone that is higher when the dosage form is administered to the subject in an intact state versus when the dosage form is administered to the subject in a crushed or ground state.

A solid oral dosage form comprising:

• (a) at least one immediate release portion comprising acetaminophen and oxycodone or a pharmaceutically acceptable salt thereof;
• and
• (b) at least one extended release portion comprising acetaminophen, oxycodone or a pharmaceutically acceptable salt thereof, and an extended release component;
• wherein the total amount of acetaminophen in the dosage form is about 325 mg to about 650 mg, and the total amount of oxycodone or its pharmaceutically acceptable salt in the dosage form is about 5 mg to about 15 mg;
• and
• wherein administration of the dosage form to a subject produces a mean Tmax for oxycodone that is at least about 30 minutes greater when the dosage form is administered in a crushed or ground state versus when the dosage form is administered in an intact state.