- Subject has moderate to severe chronic noncancer pain (duration of at least 3 months)
requiring a continuous around-the-clock opioid analgesic for an extended period of
time. Conditions may include, but are not limited to, osteoarthritis, chronic low back
pain, or other opioid -responsive pain conditions.
- Subject agrees to refrain from taking opioid medications other than study drug during
the study. (The exception is during the Pre-Treatment Period when the subject may
continue current opioid therapy to guide first 4 weeks of the Treatment Period when
the subject may administer immediate-release oxycodone to support conversion to study
drug.)
- Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma,
infection, or other pain expected to be short-term (duration less than 3 months).
- Subject has a documented history of alcohol or drug abuse within 1 year prior to study
entry that in the Investigator's judgment would impact subject participation.
- Subject has ongoing or active alcohol or drug abuse that in the Investigator's
judgment would impact subject participation.
- Subject has a positive urine drug test for illicit drug use or medications at
screening without legitimate medical explanation.
- Subject has a clinically significant medical condition (e.g., cardiovascular,
neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological,
immunological, rheumatological, metabolic, or psychiatric) or physical examination,
vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities
that in the opinion of the Investigator would impact the safety of the subject during
study participation.
- If female, the subject is pregnant or breast-feeding.
- Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts,
naltrexone or acetaminophen,or pharmacological similar compounds.
- Subject is historically non-responsive to oxycodone treatment or requires greater than
160 mg oxycodone in a 24-hour time interval.