Indivior Inc., a subsidiary of Indivior PLC announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RBP-6000 buprenorphine monthly depot, an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support.
“This Fast Track designation is an important acknowledgment of the potential that RBP-6000 holds as an innovative treatment option for patients living with opioid use disorder and Indivior looks forward to working closely with the Agency,” said Shaun Thaxter, Chief Executive Officer of Indivior. “We are currently awaiting our top line RBP-6000 Phase 3 efficacy results which are still expected in Q3 2016 and we continue to estimate an approval in 2017 under the assumption of a Priority Review.”
The most commonly reported (≥ 5%) TEAEs were constipation, nausea, diarrhea, upper abdominal pain, headache, injection site pain, injection site pruritus and abnormal liver function test.
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