A Double-Blind, Placebo Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects

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 experiences 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