BioDelivery Sciences International (BDSI) has commenced a confirmatory pharmacokinetic study of a formulation of buprenorphine and naloxone using the company's BioErodible MucoAdhesive (BEMA) drug delivery technology.
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BEMA buprenorphine/naloxone which contains the same drug components as Suboxone is indicated for the treatment of opioid dependence.
The study, BNX-102, will select the final doses of BEMA Buprenorphine/Naloxone to be used in the pivotal bioequivalence study compared to Suboxone.
An earlier study, BNX-101 proved the efficacy of BEMA formulation in delivering plasma concentrations of buprenorphine in the range needed to treat opioid dependence, besides reducing the exposure of naloxone, an abuse deterrent component.
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