Indivior hails slow-release heroin treatment trial data

RBP-6000, a monthly slow-release 'depot' formulation of Buprenorphine that is applied subcutaneously to treat heroin addiction, met both its primary and secondary endpoints in the Phase III trials versus placebo.

Indivior said the results bring the "potentially transformational" drug one step closer to market, with the process on track to complete the data analysis of the trial as well as the open-label long-term assessment of the safety and tolerability of RBP-6000 by the first quarter of 2017, as previously indicated.

Subject to this and, assuming the US Food and Drug Administration (FDA) review and approval is achieved within the assumed six month priority review timeline, it is possible that a marketing authorization could be granted in the fourth quarter as the company has guided.

"This development comes at a time when there is intensified focus by the US government and regulators to address the public health epidemic of opioid abuse, addiction and overdose," said Indivior in a statement, pointing to the recent Comprehensive Addiction and Recovery Act of 2016 (CARA) legislation and the US Department of Health and Human Services (HHS) final rule, both aimed at increasing access to medication-assisted treatment for addiction.

Chief scientific officer of Christian Heidbreder added: "The treatment of opioid use disorder aims to reduce opioid drug misuse by decreasing cravings and addressing withdrawal symptoms. Treatment involves pharmacological and behavioral therapy, as well as psychosocial support to eventually end illicit drug-taking behavior."