HLS Therapeutics announces Health Canada approval of Perseris extended release for the treatment of schizophrenia.

HLS Therapeutics Inc. announced that Health Canada has approved the use of Perseris (risperidone for extended-release injectable suspension), 90 mg and 120 mg subcutaneous injection, a novel long-acting injectable of risperidone, for the treatment of schizophrenia in adults. HLS has in-licensed the exclusive rights to Perseris for the Canadian market from Indivior PLC . Risperidone is a well-established treatment for schizophrenia, and Perseris delivers its active ingredient, risperidone, in an extended-release delivery system with no loading doses or oral supplementation recommended. Sustained therapeutic levels of risperidone are released over a one-month period from a single injection. Perseris is approved by Health Canada and the FDA and is the first once-monthly subcutaneous risperidone-containing long-acting injectable indicated for the treatment of schizophrenia in adults. The Perseris approvals were based on a pivotal Phase III study in patients aged 18 to 55 years with acute exacerbations of schizophrenia (NCT 02109562). The primary efficacy endpoint measure was change in Positive and Negative Syndrome Scale (PANSS) total score at eight weeks. Both Perseris 90 mg and 120 mg doses demonstrated a statistically significant improvement compared with placebo from baseline to end of study.