The crossover study compared the pharmacokinetics between equal strengths of BioDelivery Sciences’s (BDSI’s) oral adhesive disc (called Bema Fentanyl) and Actiq, a lozenge formulation of fentanyl.
The study was conducted in 12 subjects who used both Bema and Actiq. The results show that the Bema fentanyl formulation gave greater bioavailability (absorption), higher maximum plasma concentrations and faster concentrations of fentanyl in the plasma compared to Actiq.
Cephalon has reported 2004 sales of $345 million for Actiq, and projected 2005 sales of $390 to $420 million. BDSI has previously disclosed its belief that Bema Fentanyl could potentially achieve annual peak sales of approximately $250 million for the company.
“Simply put, the results of this study demonstrate that fentanyl can potentially be delivered more effectively and easily from BDSI’s BEMA delivery system compared to Actiq. Besides allowing greater absorption of fentanyl, this study demonstrated that the BEMA disc was easier to use for the subjects in the study as it only required seconds to apply while the Actiq lozenge required active sucking for up to 30 minutes,” said Dr Andrew Finn, executive vice president of clinical and regulatory development for BDSI.