Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
Condition: Pain; Cancer
MeSH terms: Breakthrough Pain
Intervention: BEMA Fentanyl
Intervention description: buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breakthrough Pain in Cancer Patients

Summary:

      The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the
      management of breakthrough pain in cancer subjects on background opioid therapy. The standard
      of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with
      minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used,
      but because of slow and variable oral absorption, the pain control is not the best with these
      products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating
      breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick
      and is administered by continuously swabbing the interior of the subject's mouth until the
      product is dissolved (approximately 15 to 30 minutes). The buccal route of administration
      avoids the delay and variability associated with oral absorption.

      BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive)
      fentanyl, an alternative product to OTFC that does not require the subject to continuously
      paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is
      placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc
      readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of
      the disc are water soluble, so the entire dosage form dissolves within 30 minutes of
      application.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant and non-lactating female. A female of child-bearing potential is
             eligible to participate in this study if she is using an acceptable method of birth
             control.

          -  18 years or older

          -  Patient must have pain associated with cancer or cancer treatment

          -  Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000
             mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30
             mg, methadone 20 mg, and hydromorphone 7.5 mg)

          -  Regularly experience 1 - 4 breakthrough pain episodes per day that require additional
             opioids for pain control

          -  At least partial relief of breakthrough pain by use of opioid therapy

          -  Subject must be able to self-administer the study medication correctly.

          -  Subject must be willing and able to complete the electronic diary card with each pain
             episode.

          -  Signed consent must be obtained at screening prior to any procedures being performed.

        Exclusion Criteria:

          -  Psychiatric/cognitive or neurological impairment that would limit the subject's
             ability to understand or complete the diary

          -  Cardiopulmonary disease that, in the opinion of the investigator, would significantly
             increase the risk of respiratory depression

          -  Recent history or current evidence of alcohol or other drug substance (licit or
             illicit) abuse

          -  Rapidly escalating pain that the investigator believes may require an increase in the
             dosage of background pain medication during the study

          -  Moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate
             mucositis are permitted and must be instructed to not apply the BEMA disc at a site of
             inflammation)

          -  Strontium 89 therapy within the previous 6 months

          -  Any other therapy prior to the study that the investigator considers could alter pain
             or the response to pain medication.

          -  Use of an investigational drug within 4 weeks preceding this study • History of
             hypersensitivity or intolerance to fentanyl

          -  Regularly more than 4 episodes per day

          -  ECOG performance status of 4 or 5

          -  Subject is pregnant, actively trying to become pregnant, breast feeding or not using
             adequate contraceptive measures