A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

This is a multicenter, open-label study in patients 40 years and older who are undergoing a
surgical procedure.

Upon meeting all entrance criteria, patients will be administered the first dose of ST 30
mcg and will remain in the study for up to 12 hours for safety and efficacy measurements.
Patients may receive additional doses of ST 30 mcg as needed for pain management, but no
more frequently than every 60 minutes.

Inclusion Criteria:

1. Male or female patients who are 40 years of age or older.

2. Patients who have undergone a surgical procedure with general anesthesia or spinal
anesthesia that does not include intrathecal opioids during the operation.

3. Patients classified as American Society of Anesthesiologists (ASA) class IIII
(Appendix I).

Exclusion Criteria:

1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg
hydrocodone per tablet).

2. Patients with a positive drug of abuse screen unless the positive test result is
consistent with a prescribed medication.

3. Patients with a history of opioid dependence within 2 years before the start of the
study, defined as meeting the DSM-IV-TR™ Criteria for Substance Dependence specified
in Appendix II.

4. Patients who have used any illicit drugs of abuse within five years before the start
of the study.

5. Patients who have abused any prescription medication or alcohol within one year
before the start of the study.

6. Patients with an allergy or hypersensitivity to opioids.

7. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken
MAOIs within 14 days of the first dose of study drug.

8. Patients with current sleep apnea that has been documented by a sleep laboratory
study or are on home continuous positive airway pressure (CPAP).