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Buprenorphine film product approved for expanded indication

May 4, 2017
by Gary A. Enos, Editor
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The maker of the buprenorphine film product Bunavail announced this week that the Food and Drug Administration (FDA) has approved its Supplemental New Drug Application for a revised indication to include induction to treatment. The indication for Bunavail previously had covered only the maintenance phase of treatment for opioid dependence.

“The expansion of the indication for Bunavail is expected to help maintain the competitiveness of Bunavail in the market and allows [BioDelivery Sciences International Inc.] and its sales representatives to communicate the benefits of Bunavail in treating opipid dependence from induction through the longer maintenance phase of treatment,” the Raleigh, N.C.-based drug maker said in a May 2 news release.

Bunavail is a combination buprenorphine and naloxone product, one of several film product formulations of the opioid dependence treatment.