BioDelivery Sciences International, Inc. received approval of the New Drug Application for Bunavail (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA). Bunavail is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BDSI expects to launch Bunavail late in the third quarter of 2014.

Bunavail was designed using BDSI's advanced drug delivery technology, BioErodible MucoAdhesive (BEMA), allowing for the efficient and convenient delivery of buprenorphine while potentially overcoming some of the administration challenges presented by the sublingual (under the tongue) dosage forms currently available. Bunavail has twice the bioavailability (drug absorbed into the body) of buprenorphine compared to Suboxone, the market leader in this category. As a result of the improved absorption of buprenorphine with Bunavail, which is the direct result of the BEMA technology, plasma concentrations of buprenorphine comparable to Suboxone can be achieved with half the dose, which may help to reduce the potential for misuse and diversion and potentially lessen the incidence of certain side effects.

For more details, go to: http://bdsi.investorroom.com/2014-06-06-BioDelivery-Sciences-Receives-FDA-Approval-for-BUNAVAIL-buprenorphine-and-naloxone-Buccal-Film-for-the-Maintenance-Treatment-of-Opioid-Dependence