Biodelivery Sciences files Bunavail at FDA for Opioid Dependence
BioDelivery Sciences International, Inc. announced that it has submitted a New Drug Application (NDA) to the FDA for Bunavail (buprenorphine naloxone buccal film) for the maintenance treatment of Opioid Dependence. Under the 505(b)(2) regulatory statute, Bunavail will be subject to a ten month review.
Bunavail uses BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology to deliver buprenorphine across the buccal mucosa (inside lining of the cheek). Bunavail is formulated with the abuse deterrent agent naloxone and is designed to efficiently and conveniently deliver buprenorphine while potentially overcoming some of the challenges with other dosage forms.
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