Controlled release hydrocodone formulations

16-22. (canceled)

27-31. (canceled)

A solid oral controlled-release dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof together with an amount of a controlled release material sufficient to render said dosage form suitable for twice-a-day administration to a patient, said dosage form, after a first administration to the patient, providing a Tmax of hydrocodone in-vivo at from about 2 to about 8 hours, and providing a C12/Cmax ratio of 0.55 to 0.85, said dosage form providing a therapeutic effect for about 12 hours.

-42. (canceled)

-49. (canceled)

A method of providing effective analgesia in a human patient for at least about 12 hours comprising orally administering a dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof and a controlled release material to render said dosage form suitable for twice-a-day administration to a human patient, said dosage form providing after a first administration to the human patient a C12/Cmax ratio of 0.55 to 0.85 and a therapeutic effect for at least about 12 hours.

A process for the preparation of a solid oral controlled-release dosage form, comprising incorporating an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof into a controlled release material to make a dosage form suitable for twice-a-day administration to a human patient, wherein said dosage form after a first administration to the human patient provides a C12/Cmax ratio of 0.55 to 0.85 and a therapeutic effect for at least about 12 hours.

A solid oral controlled-release dosage form, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof and a controlled release material to render said dosage form suitable for twice-a-day administration to a human patient population, said dosage form, after a first administration to the human patient population, providing a mean C12/Cmax ratio of 0.55 to 0.85, said dosage form providing a therapeutic effect for at least about 12 hours.

A solid oral controlled-release dosage form, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof and a controlled release material to render said dosage form suitable for twice-a-day administration to a human patient, said dosage form providing a dissolution rate in-vitro of the hydrocodone dosage form when measured by the USP Paddle or basket method at 100 rpm in 900 ml aqueous buffer at a pH of 1.2 at 37° C. is from about 25 to about 65% by weight hydrocodone or salt thereof released after 2 hours, from about 45 to about 85% by weight hydrocodone or salt thereof released after 4 hours, and greater than about 60% by weight hydrocodone or salt thereof released after 8 hours.