152
Participants
Start Date
February 28, 2006
Primary Completion Date
April 30, 2007
Study Completion Date
April 30, 2007
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.
Placebo
PPD Development, Wilmington
Lead Sponsor
BioDelivery Sciences International
INDUSTRY