26th May 2016 16:48
LONDON (Alliance News) - Indivior PLC on Thursday said its subsidiary Indivior Inc has received Fast Track designation for its RPB-6000 Buprenorphine drug, used for the treatment of opiod use disorder, by the US Food and Drug Administration.
The pharmaceutical business said the Fast Track designation is granted to facilitate and expedite development and review for drugs that are intended to treat a serious condition, with nonclinical or clinical data that demonstrate the potential to address an unmet medical need.
"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 Chief Executive Shaun Thaxter.
"We are currently awaiting our top line RBP-6000 Phase 3 efficacy results which are still expected in the third quarter of 2016 and we continue to estimate an approval in 2017 under the assumption of a priority review," Thaxter added.
Shares in Indivior closed down 1.0% at 173.13 pence on Thursday.
By Hannah Boland; [email protected]; @Hannaheboland
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