BioDelivery Sciences Reports More Positive Test Results on Lead Drug

Morrisville, N.C. — Drug development firm BioDelivery Sciences International is reporting more positive news about its lead candidate which is intended to treat breakthrough cancer pain.

In a Phase III clinical trial testing the efficacy of its BEMA Fentanyl product, BDSI reported Monday that the drug met a key endpoint – speed of delivery of onset of the medication within 15 minutes. The drug was “significantly higher” than placebo, the company said.

On April 25, BDSi reported that the drug met a 30-minute timeline efficacy endpoint.

BEMA Fentanyl combines the narcotic fentanyl with a dissolvable disc that is designed to dissolve in the inner cheek of the mouth.

Patients also reported a statistically superior satisfaction with the product compared to placebo.

BDSI plans to file a new drug application for the product with the Food and Drug Administration in the third quarter this year.