Indivior a step closer to US opioid market
- Shares of British biotech Indivior surged on the London Stock Exchange, jumping as much as 15%, after the company announced positive Phase 3 results of its opioid dependence treatment drug.
- The company expects further results from the study comparing RBP-6000 in the first quarter of 2017 and said the product could reach the U.S. market before the end of next year.
- The study showed that both dosage regimens of RBP-6000 achieved the primary endpoint of the cumulative distribution function (CDF) of the percentage of urine samples negative for opioids combined with reports from patients saying they had not used opioids at the end of 24 weeks.
Just as concerns about opioid abuse and dependence hit a fever pitch in the U.S., the Reckitt Benckiser spinoff is one step closer to reaching the world's largest pharmaceutical market with a monthly treatment that could help tackle the problem.
RBP-6000 is a monthly subcutaneous injection that helps patients deal with opioid dependence and could be a particular game-changer for those patients that are not compliant with a daily pill regimen.
The trial included 489 patients who were not currently getting treatment for opioid dependence, but wanted a medication to help with the problem. Patients were given an induction phase of Suboxone, a sublingual film containing naloxone and buprenorphine. After the three-day run-up time, patients were randomized to either a low of high dose of RBP-6000 or placebo.
The monthly injection is meant to reduce opioid abuse by decreasing cravings and withdrawal symptoms.
"We believe that RBP-6000 can potentially transform the treatment of opioid dependence, if approved, by possibly reducing patients' treatment administration days from 365 a year to 12. RBP-6000 was designed to offer physicians the potential for increased certainty of treatment adherence, and developed with the desire to help mitigate abuse, misuse and diversion of medication," said CEO Shaun Thaxter in a statement.
RBP-6000 is a sustained-release version of buprenorphine that has received Fast Track designation from the U.S. Food and Drug Administration. Indivior already markets an oral version of the substance and is also developing a schizophrenia treatment that is in late stages.
- Indivior Statement
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