Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy

Condition(s) targeted: Pain; Cancer

Intervention: BEMA Fentanyl (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: BioDelivery Sciences International

Official(s) and/or principal investigator(s):
David Blum, MD, Study Chair, Affiliation: BioDelivery Sciences International

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.

Official title: An Open Label, Long-Term Treatment Evaluation of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: Evaluation of the safety and tolerability of BEMA Fentanyl. The safety assessments will include oral exams for mucosal irritation, adverse events, vital signs, physical examinations and concomitant medications.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

ResearchPoint, Austin, Texas 78746, United States

Starting date: February 2006
Ending date: June 2008
Last updated: June 10, 2008