Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

Inclusion Criteria:

- Patient has completed 12 weeks of blinded treatment in the SPI/0211OBD-0631 or
SPI/0211OBD-0632 study.

- Patient will continue to be treated consistently for chronic, non-cancer-related pain
with any full agonist opiate and will continue opiate therapy for the duration of the
study.

- Patient must be willing to continue to abstain from use of disallowed medications as
defined per protocol.

Exclusion Criteria:

- Patient has newly diagnosed impaired renal function identified at the Screening Visit
(i.e., serum creatinine concentration > 1.8 mg/dL).

- Patient has experienced an unexplained and/or clinically significant weight loss
defined as > 5% within 90 days prior to Screening Visit.

- Patient plans to participate in another trial with an investigational drug or device
during the course of the extension study.