BDSI's BEMA fentanyl impresses in Ph III trial

USA-based drugmaker BioDelivery Sciences International says that its BEMA fentanyl product has achieved further statistically-significant efficacy results in a Phase III trial assessing it as a breakthrough pain therapy in cancer patients. Specifically, the drug reached the secondary efficacy endpoint of improving summary pain intensity at 15 minutes (SPID 15).

BEMA fentanyl consists of a small, disolvable polymer disc, formulated with the narcotic opioid narcotic fentanyl, that is administered via attachment to the buccal membrane. Earlier this year, the firm announced that the product had met primary efficacy goals, defined as SPID 30. The latest results build upon the existing data, providing further evidence of its utility.

The company said that it plans to submit a New Drug Application requesting approval for the agent to the Food and Drug Administration in the third quarter of the year, and has scheduled a pre-submission meeting for June 28.