Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
1. previously qualified for and participated in study FEN-202 for at least 2 weeks,
2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
3. provide signed informed consent at screening prior to any study procedures.
1. they have developed a new medical condition after initial enrollment in FEN-202
which, in the opinion of the investigator, would preclude safe and appropriate use of
BEMA Fentanyl or participation in this study, or
2. there is evidence of improper use of the study drug.
Type of Study:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of BEMA Fentanyl (any dose) as demonstrated by the occurrence of drug-related SAEs.
Outcome Time Frame:
David Blum, MD
BioDelivery Sciences International
United States: Food and Drug Administration