Indivior's schizophrenia treatment gets FDA green light
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Indivior's extended-release injectable treatment for schizophrenia in adults has been approved by US drug regulators.
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The US Food & Drug Administration approved the FTSE 250 company's formulation, called Perseris, of risperidone, a well-established medicine for schizophrenia.
Perseris uses an extended-release delivery system to form a subcutaneous "depot", which is slowly released into the body over a number of weeks, providing a sustained levels of risperidone over the month.
Indivior said it was preparing for a full promotional launch for the treatment in February, as long as the US Court of Appeals upholds its injunction to stop Dr Reddy's Laboratories producing a generic version of one of Indivior's other drugs, Suboxone, for the treatment of opioid addiction.
The approval by the FDA was a new treatment option for doctors in the US to treat schizophrenia, said Indivior chief executive Shaun Thaxter.
"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."
The approval was given on the back of a randomized, double-blind, placebo-controlled eight-week study of 354 patients, where the treatment was demonstrated by a statistically significant improvement in the Positive and Negative Syndrome Scale medical scale, which is used for measuring symptom severity of patients with schizophrenia, and in the Clinical Global Impression Severity of Illness scale, at day 57 of the trial.