Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time

Exclusion Criteria

• •Patients who were enrolled in study 3079 but did not complete the 12-week, double-blind, placebo-controlled, randomized study may not be enrolled into this study.
• •The patient has known or suspected hypersensitivities, allergies, or other contraindications to the study drug or its excipients.
• •The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
• •The patient has a medical or psychiatric condition/disease that, in the opinion of the investigator, would compromise collected data.
• •The patient is taking a total (i.e., including around-the clock \[ATC\] and rescue medications) of more than 135 mg/day of oxycodone or equivalent for 14 days prior to screening.
• •The patient has a history of suicidality.
• •The patient has a diagnosis of chronic headache or migraine as the primary painful condition under study.
• •The patient is expected to have surgery during the study and it is anticipated that the surgery will alleviate the patient's pain.
• •The patient is pregnant or lactating.
• •The patient has active malignancy.
• •The patient has human immunodeficiency virus (HIV).
• •In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination and/or clinical laboratory test values.
• •The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids.
• •The patient has participated in a study involving an investigational drug in the previous 30 days (excluding those who participated in study 3079).
• •The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
• •The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.
• •The patient is involved in active litigation in regard to the chronic pain currently being treated.
• •The patient has a positive urine drug screen (UDS) for an illicit substance or medication not prescribed by the physician currently treating the chronic pain.
• •The investigator feels that the patient is not suitable for the study.