BDSI to Initiate Phase III Clinical Trials of BEMA Fentanyl

BioDelivery Sciences International has received confirmation from the FDA that the company will be able to utilize the FDA's 505(b)(2) regulatory pathway for regulatory approval consideration of its licensed BEMA fentanyl formulation.

As a result of this guidance, BDSI stated that it plans to enter BEMA fentanyl into Phase III clinical studies in the second half of 2005. BDSI is developing BEMA fentanyl for the treatment of breakthrough pain in cancer patients.