HLS is seeking approval for PERSERIS with an indication for the treatment of schizophrenia in adults.
HLS has in-licensed the exclusive rights to PERSERIS for the Canadian market from
'Schizophrenia is a critical and fragile disease state where the treatment requirements are immense and complex. As a result, treatment adherence is a significant challenge,' said
Risperidone is a well-established treatment for schizophrenia and PERSERIS uses a sub-cutaneous extended-release delivery system that forms a depot providing sustained therapeutic levels of risperidone over a one-month period from a single injection.
About PERSERIS
PERSERIS is approved by the FDA and is the first once-monthly subcutaneous risperidone-containing long-acting injectable indicated for the treatment of schizophrenia in adults. The PERSERIS approval by the FDA was based on a pivotal Phase 3 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.
The systemic safety profile of PERSERIS is consistent with the known safety profile of oral risperidone.1 The most common systemic adverse reactions in the pivotal Phase 3 trial (in 5 percent of PERSERIS patients and greater than twice placebo) were increased weight, sedation/somnolence and musculoskeletal pain. The most common injection site reactions (5 percent of all patients across PERSERIS and placebo groups) were injection site pain and reddening of the skin.1
ABOUT
Formed in 2015, HLS is a specialty pharmaceutical company focused on the acquisition and commercialization of late stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages.
FORWARD LOOKING INFORMATION
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