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

Inclusion Criteria:

• The patient must be willing and able to successfully self-administer the study drug,comply with study restrictions, and return to the clinic for scheduled study visits asspecified in this protocol.

• The patient has either completed Cephalon study 3079 or has chronic pain of at least 3months duration prior to entering this study associated with any of the followingconditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury,complex regional pain syndrome, back pain, neck pain, osteoarthritis, or rheumatoidarthritis. Patients with other painful conditions may qualify for the study withpermission from the Cephalon medical monitor or designee.

• Those patients who completed the 12-week, double-blind, placebo-controlled, randomizedstudy (study 3079) and are willing to re-titrate study drug to an effective dose ofhydrocodone extended-release tablets are eligible to enter this study.

• The patient is able to speak English, willing to provide written informed consent, andsign a written opioid agreement, to participate in this study.

• The patient is 18 through 80 years of age (inclusive) at the time of entering this orthe previous study (study 3079).

• Women of childbearing potential (not surgically sterile or 2 years postmenopausal),must use a medically accepted method of contraception and must agree to continue useof this method for the duration of the study and for 30 days after participation inthe study, and have a negative pregnancy test at screening.

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 thisstudy.

• The patient has known or suspected hypersensitivities, allergies, or othercontraindications to the study drug or its excipients.

• The patient has a recent history (within 5 years) or current evidence of alcohol orother substance abuse.

• The patient has a medical or psychiatric condition/disease that, in the opinion of theinvestigator, would compromise collected data.

• The patient is taking a total (i.e., including around-the clock [ATC] and rescuemedications) of more than 135 mg/day of oxycodone or equivalent for 14 days prior toscreening.

• The patient has a history of suicidality.

• The patient has a diagnosis of chronic headache or migraine as the primary painfulcondition under study.

• The patient is expected to have surgery during the study and it is anticipated thatthe 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 significantdeviation from normal in the physical examination and/or clinical laboratory testvalues.

• The patient has cardiopulmonary disease that would, in the opinion of theinvestigator, significantly increase the risk of treatment with potent syntheticopioids.

• The patient has participated in a study involving an investigational drug in theprevious 30 days (excluding those who participated in study 3079).

• The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days beforethe first treatment with study drug.

• The patient has any other medical condition or is receiving concomitantmedication/therapy (e.g., regional nerve block) that would, in the opinion of theinvestigator, 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 currentlybeing treated.

• The patient has a positive urine drug screen (UDS) for an illicit substance ormedication not prescribed by the physician currently treating the chronic pain.

• The investigator feels that the patient is not suitable for the study.