28th Apr 2016 13:36
LONDON (Alliance News) - Indivior PLC said Thursday that phase I study of its treatment for opioid dependence RBP-6300 did not achieve the anticipated pharmacokinetic profile in humans to justify proceeding further with it, and the approval of schizophrenia treatment RBP-7000 is likely to be delayed.
The company is currently evaluating alternative options for the development of an orally bioavailable buprenorphine-based product with abuse deterrent properties, it said.
Elsewhere, there was a manufacturing issued identified with one out of the six stability batches of RBP-7000 that are required for a new drug application submission. Indivior believes this issue is now rectified, and it will manufacture additional batches to provide the required data.
As a result there is likely to be a delay to the approval date of RBP-7000 until mid-2018, Indivior said. A clinical program for the drug, currently concluding a phase III long term safety trial, is still on track with its original timeline.
Shares in Indivior were down 5.3% at 159.50 pence Thursday afternoon.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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