Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

April 30, 2007

Study Completion Date

April 30, 2007

Conditions
PainCancer
Interventions
DRUG

BEMA™

BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) 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 soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.

DRUG

Placebo

Trial Locations (1)

28412

PPD Development, Wilmington

All Listed Sponsors
lead

BioDelivery Sciences International

INDUSTRY