Indivior submits new drug application to U.S. FDA for RBP-6000 buprenorphine monthly depot

Indivior

30 May 2017 - A potential novel long-acting, sustained release product candidate for treatment of opioid use disorder.

Indivior today announced that the Company has submitted a new drug application to the U.S. FDA to seek marketing approval for RBP-6000, the Company’s investigational, once-monthly injectable buprenorphine for the treatment of moderate-to-severe opioid use disorder as part of a complete treatment plan to include counselling and psychosocial support. 

This application includes the results from the pivotal Phase 3 study assessing the efficacy and safety of RBP-6000 which met both the primary and secondary endpoints.

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Michael Wonder

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Michael Wonder

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Medicine , US , Submission