Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. announced last week that they have submitted a New Drug Application (NDA) for Buprenorphine HCl Buccal Film to the FDA for approval. Buprenorphine HCl Buccal Film is under development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The HCI Buccal Film is administered via a thin strip placed inside the cheek which then dissolves. Endo’s flagship clinical trials for the drug were two double-blind, placebo-controlled studies of efficacy for the treatment of chronic lower back pain. The company claims that the pain intensity of patients was lower during the study period at the end of twelve weeks and that the film strip created fewer typical opioid side effects.
Read the full release from BioDelivery Sciences here.