The regulatory agency also granted priority review designation to the company’s NDA. Indivior’s application was supported by data from a pivotal Phase III trial, which evaluated the safety and efficacy of RBP-6000.
The therapy would be the first once-monthly buprenorphine injection treatment for opioid use disorder, if it wins approval by the FDA. The depot formulation is delivered by healthcare professionals using Indivior’s Artigel delivery system and is designed to make abuse and diversion of the drug challenging.
“FDA acceptance with a Priority Review designation of our NDA application for RBP-6000 represents a significant milestone for our company as well as for the broader field of opioid use disorder treatment,” CEO Shaun Thaxter said in prepared remarks. “This milestone is the result of our clear focus on developing treatments that deliver on the unmet needs of patients, along with our relentless advocacy for evidence-based medication-assisted treatment (MAT) as a key part of the addiction recovery equation.”
“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,” chief scientific officer Christian Heidbreder added. “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.”
The company said it expects an FDA advisory committee to meet for RBP-6000 in the fourth quarter of this year.