19th Nov 2018 14:09
LONDON (Alliance News) - Indivior PLC on Monday said its extended-release drug Perseris is now available in the US for the treatment of schizophrenia in adults.
Perseris is a slow-release injectable form of Risperidone and is now available in the US, having been approved by the Food & Drug Administration for use in adult schizophrenic patients.
The injection provides sustained levels of the antipsychotic drug Risperidone, an established treatment for schizophrenia, over a one-month period.
FDA approval for Perseris was granted based on results from its phase three study of the product in 354 patients over an eight week period.
Indivior said it anticipates and is preparing for a full promotional launch by its salesforce for Perseris by February 2019.
This launch is dependent upon the US Court of Appeals upholding its injunction against a generic form of one of Indivior's Suboxone film opiate addiction product. The generic has been developed by Dr Reddy's Laboratories Ltd.
Schizophrenia symptoms include hallucinations and delusions, as well as changes in behaviour. This can make it more difficult for patients to maintain treatment over time, and relapse is made more likely when treatment is interrupted.
Indivior Chief Executive Shaun Thaxter said: "We understand the complex patient journey of people living with schizophrenia and recognize the important role that long-acting injectables can play. Perseris is a demonstration of our ongoing commitment to developing innovative treatments for people living with this debilitating condition."
Indivior shares were up 3.3% in London on Monday at 209.00 pence.
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