FDA, UK Biotech

Indivior gets a speedy review for opioid addiction drug as FDA vows to fight a crisis

With the FDA vowing to do everything in its power to help fight the country’s opioid addiction crisis, regulators have handed Indivior a pass onto the inside track at the agency, promising a speedy review of its opioid addiction therapy.

The FDA’s priority review process slashes 4 months off the standard 10-month approach. That means Indivior {LON: INDV} will be up for a decision by the end of November for RBP-6000, a once-monthly slow-release version of the opioid dependence drug buprenorphine.

Christian Heidbreder

The big idea behind RBP-6000 is simple. By using an injectable that is delivered only in a practitioner’s office, 12 times a year, they closely control the drug they’re handing out as well as compliance, replacing the daily therapeutic approach. And in the Phase III, the drug beat out a placebo in keeping urine samples free of opioids.

“We are excited about FDA’s acceptance with Priority Review designation of our NDA application for RBP-6000, which we believe will represent an entirely new treatment paradigm if approved,” said Christian Heidbreder, the CSO of the UK biotech. “We look forward to continuing to work closely with the Agency as they review our New Drug Application and bring this potential innovative treatment option to patients and physicians. The FDA has set a PDUFA target action date of November 30, 2017.”


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RAPS Regulatory Convergence 2017