Indivior hit by Phase I trial failure and manufacturing issue

Indivior has abandoned further development of a pill to treat heroin addiction and said the potential approval of a monthly treatment for schizophrenia was likely to be delayed after a external manufacturing issue.

The FTSE 250 drug developer said it was giving up on the development of a swallowable capsule version of its Buprenorphine Hemiadipate drug to treat opioid dependence after human trials did not work out as hoped.

"The drug did not achieve the anticipated PK (pharmacokinetic) profile in humans to justify proceeding further with this technology," Indivior said, adding that it was mulling alternative options for the development of an "orally bioavailable buprenorphine-based product with abuse deterrent properties".

Meanwhile, the company, which was spun out of Reckitt Benckiser in December 2014, revealed an external manufacturing issue had been identified with one of the batches of its 'RBP-7000' Risperidone monthly depot required for the new drug application.

Management said they believed the manufacturing issue had been rectified and additional batches will be manufactured to provide the required data.

"This will result in a delay to the likely approval date until mid-2018. However, the clinical program, currently concluding its Phase III long-term safety trial, is still on track with its original timeline," they added.

Shares in Invidior were down 3.7% to 162.1p by 1515 BST on Thursday.