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news.A phase 3 clinical trial of Indivior’s RBP-6000 buprenorphine monthly depot, a new drug for the treatment of opioid use disorder, has met both primary and secondary endpoints versus placebo.
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RBP-6000 is an investigational buprenorphine sustained-release formulation, which uses the company’s Atrigel delivery system
Indivior said if granted marketing authorization in the US, the drug will provide a new option to help address the unmet treatment needs of patients as they work to regain control of their lives.
The phase 3 study was designed to evaluate the efficacy of monthly subcutaneous (SC) injections of RBP-6000 in two dosing regimens featuring either 300 mg buprenorphine for six injections, or 300 mg for two injections.
They were followed by 100 mg buprenorphine for four injections, compared with placebo over a six-month dosing period in subjects not currently in treatment but seeking medication-assisted treatment for opioid use disorder.
In the study, RBP-6000 achieved the primary endpoint of the cumulative distribution function (CDF) of the percentage of urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from week 5 through week 24 (p<0.0001 for both dosage regimens vs. placebo).
Indivior said the key secondary endpoint was treatment success defined as any subject with more than or equal to 80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use from week 5 through week 24.
The secondary endpoint was also achieved for both dosage regimens at p<0.0001 versus placebo.
Indivior CEO Shaun Thaxter said: “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.
“We look forward to working with the FDA to bring this important new therapy to patients living with opioid use disorder.”
Image: RBP-6000 is a subcutaneous long-acting monthly depot injection that delivers a sustained-release formulation of buprenorphine. Photo: courtesy of jk1991 at FreeDigitalPhotos.net.