Posted 10/26/2015 11:50 PM (GMT -7)
FDA Approves Belbuca (buprenorphine) Buccal Film for Chronic Pain Management
DUBLIN and RALEIGH, N.C., October 26, 2015 -- Endo Pharmaceuticals Inc. BioDelivery Sciences International, Inc.announced today that the U.S. Food and Drug Administration (FDA) has approved Belbuca (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Belbuca, which is the first and only buprenorphine developed with a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management, is expected to be commercially available in the U.S. during the first quarter of 2016 in seven dosage strengths, allowing for flexible dosing ranging from 75 μg to 900 μg every 12 hours. This enables physicians to individualize titration and treatment based on the optimally effective and tolerable dose for each patient.
“We are proud to add Belbuca to our diversified portfolio of branded and generic products and we look forward to preparing for the expected U.S. launch of the drug in early 2016.”