Indivior firms schizophrenia drug plans after trial results
Indivior said it expected to file a new drug application for its one-monthly schizophrenia treatment after getting positive results from recent clinical trials.
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Phase-three trials to evaluate the long-term safety and tolerability of Indivior's monthly 'depot' injection of form of its risperidone drug, known as RBP-7000, found no new safety issues in around 500 patients over a 12-month period.
Measures of the efficacy in the trial demonstrated patients "remained stable or improved" over the period, while there was no deleterious effect on health from the treatment, with high medication satisfaction and preference to treatment, and good long-term prognosis for stability.
Indivior said this was the first demonstration of safety and durability of effect for a once-monthly injectable form of risperidone administered subcutaneously in a long-term clinical trial.
Chief scientific officer Christian Heidbreder said the group was targeting the filing of a new drug application with the US Food & Drugs Administration (FDA) in the fourth quarter of 2017,
"Schizophrenia is a chronic, severe and disabling brain disorder that affects an estimated 23m people worldwide," he said.
"With these positive preliminary findings, we are expeditiously moving toward filing a new drug application".