Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets

Inclusion Criteria:

1. Patients must have participated in and completed the entire double-blind treatment
period on study drug through the final study visit (visit 12) of study 3103. NOTE:
Patients who had a final on-treatment visit (visit 11.5) are not permitted to
participate in study 3104.

2. The patient is able to speak English and is willing to provide written informed
consent for study 3104, including re-signing a written opioid agreement, to
participate in this study.

3. Women of childbearing potential (not surgically sterile or 2 years postmenopausal)
must use a medically accepted method of contraception, agree to continue use of this
method for the duration of the study and for 30 days after participation in the
study, and have a negative pregnancy test at screening. Acceptable methods of
contraception include barrier method with spermicide, intrauterine device (IUD), or
steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction
with a barrier method. NOTE: A woman will be considered surgically sterile if she has
had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral
oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy.

4. The patient must be willing and able to successfully self-administer the study drug,
comply with study restrictions, and return to the study center for scheduled study
visits, as specified in the protocol.

5. The patient must not participate in any other study involving an investigational
agent (excluding those who participated in study 3103) while enrolled in the present
study.

Exclusion Criteria:

1. The patient's current source of pain is different from the low back pain the patient
was experiencing at entry into study 3103. NOTE: Any additional source of pain for a
patient must be discussed with the medical monitor.

2. The patient has current evidence of alcohol or other substance abuse with the
exception of nicotine or caffeine.

3. The patient has developed, during study 3103, a medical or psychiatric disease
(including suicidality) that, in the opinion of the investigator, would compromise
collected data.

4. The patient is expected to have surgery during the study.

5. The patient is pregnant or lactating.

6. The patient has developed an active malignancy (excluding basal cell carcinoma)
during study 3103.

7. The patient has known human immunodeficiency virus (HIV).

8. 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.

9. The patient has developed cardiopulmonary disease that would, in the opinion of the
investigator, significantly increase the risk of treatment with opioids.

10. The patient is receiving a monoamine oxidase inhibitor (MAOI).

- Other exclusion criteria apply.