Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
Condition: Moderate-to-severe Acute Pain
MeSH terms: Acute Pain
Intervention: Zalviso™ 15 mcg
Intervention description: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours
Intervention MeSH terms: Sufentanil; Dsuvia
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual
      tablet system) 15 mcg
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients who were 18 years of age or older.

          2. Patients who were scheduled to undergo surgery under general or spinal anesthesia that
             does not include intrathecal opioids during the operation.

          3. Patients classified as American Society of Anesthesiologists (ASA) class I - III
             (Appendix I).

          4. Female patients of childbearing potential must have been using an effective method of
             birth control at the time of screening visit and for 30 days following the end of the
             study period. Acceptable methods of birth control included oral or transdermal
             contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant
             or injection, abstinence, vaginal ring, or sterilization of partner. The reason for
             non-child bearing potential, such as bilateral tubal ligation, bilateral oophorectomy,
             hysterectomy, or postmenopausal for > 1 year, was specified. Patients using hormonal
             forms of contraception were also willing to use a barrier method of contraception from
             screening through 30 days following the study period.

          5. Post-surgical patients who had been admitted to the PACU, and were expected to have
             acute pain requiring opioids for 24 - 72 hours after surgery.

        Exclusion Criteria:

          1. Patients who had taken an opioid for more than 30 consecutive days, at a daily dose of
             15 mg or more 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 who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken
             MAOIs within 14 days of the first dose of study drug.

          3. Patients with current sleep apnea that had been documented by a sleep laboratory study
             or were on home continuous positive airway pressure (CPAP).

          4. Patients with an allergy or hypersensitivity to opioids.

          5. Patients who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken
             MAOIs within 14 days of the first dose of study drug.

          6. Patients with current sleep apnea that had been documented by a sleep laboratory study
             or were on home continuous positive airway pressure (CPAP).

          7. Patients who were receiving oxygen therapy at the time of screening.