www.fdanews.com/articles/187842-indiviors-extended-release-schizophrenia-treatment-approved
Indivior’s Extended Release Schizophrenia Treatment Approved
August 2, 2018
The FDA approved Indivior’s Perseris (risperidone), a monthly long-acting injectable for treatment of schizophrenia.
The FDA based its approval of the extended-release subcutaneous on an eight-week study of 354 patients.
The safety profile of the drug is consistent with the known safety profile for risperidone, with increased weight and musculoskeletal pain among the most common adverse reactions.