Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain
Condition: Cancer; Pain
MeSH terms: Cancer Pain
Intervention: Fentanyl sublingual spray
Intervention description: Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 319.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for
      the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their
      persistent cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects who have completed the Double-blind Period and Final Visit of protocol
        INS-05-001(NCT00538850), Multicenter Randomized Double-blind Trial of Fentanyl Sublingual
        Spray for the Treatment of Breakthrough Cancer Pain are eligible for participation in this
        open-label extension study.

        All de novo subjects must meet all of the following criteria to be eligible for
        participation in the study:

          1. Male or female, > 18 years of age.

          2. Diagnosis of cancer.

          3. Opioid treatment. Patients who are treated with opioids are defined as those patients
             who are taking at least 60 mg of oral morphine/day, at least 25 µg of transdermal
             fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of oral
             hydromorphone/day or an equianalgesic dose of another opioid for > 7 days for
             cancer-related pain.

          4. Experience persistent pain related to the cancer or its treatment of moderate or
             lesser intensity in the 24 hours prior to assessment by a verbal rating scale at the
             Screening Visit.

          5. Experience on average 1 to 4 breakthrough cancer pain episodes per day usually at
             least partially controlled by supplemental medication of at least 5 mg
             immediate-release morphine or an equivalent short-acting opioid (eg, oxycodone,
             hydrocodone, or codeine with acetaminophen).

          6. Able to evaluate pain relief, assess medication performance, report adverse events
             (AEs), report use of the study drug or supplemental medication (a caregiver may
             provide the subject the medication).

          7. Able and willing to give informed consent.

          8. Women of childbearing potential must have a) a negative urine pregnancy test, b) not
             be breast feeding and c) agree to practice a reliable form of contraception.

        Exclusion Criteria:

          1. Intolerable side effects to opioids or fentanyl.

          2. Rapidly increasing/uncontrolled pain.

          3. A history of major organ system impairment or disease, that in the Investigator's or
             his/her designee's opinion could increase the risk associated with the use of opioids.

          4. Uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP >
             90 mm Hg on 2 occasions at least 6 hours apart) despite antihypertensive therapy, or
             has a history of hypertensive crisis within the past 2 years.

          5. A recent history (within the past 2 years) of transient ischemic attacks, neural
             vascular disease, stroke, or cerebral aneurysms.

          6. Serum creatinine, ALT or AST that is greater than 3 times the upper limit of normal.

          7. Diagnosis of sleep apnea.

          8. Brain metastases with signs or symptoms of increased intracranial pressure.

          9. Inability to assess pain or response to pain medications for any reason, including
             psychiatric disorder, concurrent medical disorder, or concomitant therapy.

         10. Has used methadone within 14 days of the Screening Visit.

         11. Received an investigational study product(s) within 30 days of the Screening Visit.

         12. Use of monoamine oxidase (MAO) inhibitors within 14 days of the Screening Visit.