BioDelivery Sciences set to file for Suboxone copy drug 2nd-qtr 2013

17 September 2012

US drugmaker BioDelivery Sciences International (Nasdaq: BDSI) announced a positive outcome of its pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX), which is being developed for the potential treatment of opioid dependence and utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist naloxone.

Based on the positive outcome of this study, BDSI continues to anticipate that it will be in a position to submit a New Drug Application to the US Food and Drug Administration for BNX during the second quarter of 2013. The product is a generic version of UK-based Reckitt Benckiser’s (LSE: RB) Suboxone, an opiate addiction treatment which lost its patent exclusivity status in 2009 but has still not faced generic competition.

Threat to Reckitt pharma business

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