Indivior presents Phase III data on sustained-release opioid addiction therapy

UK-based Indivior (LSE: INDV) has presented Phase III results from a trial into RBP-6000, an investigational once-monthly therapy for addiction to opioids.

Markets reacted positively to the data, adding over 2% to the company’s share price.

RBP-6000 is a sustained-release formulation of buprenorphine which uses the Atrigel delivery system, under investigation as a therapy in combination with a complete treatment plan, to include counseling and psychosocial support.

The 24-week study met its primary endpoints for both dosage regimens of RBP-6000, which demonstrated clinically- and statistically-significant differences in percentage abstinence and treatment success, defined as any subject with ≥80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use from Weeks 5 to 24, compared to placebo.

Christian Heidbreder, chief scientific officer of the opioid addiction treatment specialist, said: "The clinical data from our Phase III study also showed that outcomes with RBP-6000 are consistent across other secondary clinical endpoints, including control of craving and withdrawal symptoms, as compared to placebo.”

The company recently submitted a New Drug Application in the USA for the drug.

The company has multiple regulatory approvals, including in the USA and Europe, for its main product line, Suboxone (buprenorphine and naloxone), indicated for treatment of opioid dependence.

Based on 2015 data from the most recent National Survey on Drug Use and Health report, 11.5 million American adults engaged in misuse of prescription pain relievers, including opioids, in the last month.