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

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.

What this study is about