FDA approves Bunavail for Opioid Dependence - BioDelivery Sciences
BioDelivery Sciences has received approval of the New Drug Application (NDA) for Bunavail (buprenorphine and naloxone) buccal film (CIII) from the FDA, 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.
Approval was based on a Phase III clinical study in 249 patients who were converted from Suboxone sublingual tablet or film to Bunavail. In this study, Bunavail demonstrated favorable safety and efficacy in the maintenance treatment of opioid dependence as demonstrated by the high study retention rate and the low frequency of patients with positive urine tests for non-prescribed opioids over the 12-week period.
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