Fast Track designation is granted to facilitate and expedite development and review for drugs that are intended to treat a serious condition and with nonclinical or clinical data that demonstrate the potential to address an unmet medical need. By granting this designation, FDA agrees that RBP-6000 meets these criteria.
"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."
To date, 2 Phase 1, 1 Phase 2 and 1 Phase 2A clinical studies have been completed.
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.