Sustained release dosage forms for twice daily oral dosing to a
human patient for providing relief from pain are provided. The sustained release
dosage form comprises an
immediate release component and a sustained release component, wherein the
immediate release component and the sustained release component collectively contain a therapeutically effective amount of an
opioid analgesic and a therapeutically effective amount of nonopioid
analgesic. In a preferred embodiment, the nonopioid
analgesic is
acetaminophen and the
opioid analgesic is
hydrocodone and pharmaceutically acceptable salts thereof, and in preferred embodiments, the pharmaceutically acceptable salt is bitartrate. The dosage forms produce
plasma profiles in a patient characterized by a Cmax for
hydrocodone of between about 0.6 ng / mL / mg to about 1.4 ng / mL / mg and an AUC for
hydrocodone of between about 9.1 ng*hr / mL / mg to about 19.9 ng*hr / mL / mg (per mg hydrocodone bitartrate administered) and a Cmax for
acetaminophen of between about 2.8 ng / mL / mg and 7.9 ng / mL / mg and an AUC for
acetaminophen of between about 28.6 ng*hr / mL / mg and about 59.1 ng*hr / mL / mg (per mg acetaminophen administered) after a single
dose.