Bausch Health Canada secures a pan‑Canadian Pharmaceutical Alliance Letter of Intent for PrOKEDI® (risperidone extended‑release injectable suspension), advancing public reimbursement and nationwide access to a once‑monthly long‑acting antipsychotic for adults with schizophrenia.
Written By: Disha Jadhao, BPharm
Reviewed By: Pharmacally Editorial Team
Bausch Health Canada has secured a Letter of Intent (LOI) from the pan‑Canadian Pharmaceutical Alliance (pCPA) for PrOKEDI® (risperidone extended‑release injectable suspension), a once‑monthly long‑acting antipsychotic for adults with schizophrenia. Covering the 75 mg and 100 mg formulations, the LOI represents a key step toward public reimbursement across Canada. It establishes a pathway for negotiations with provincial and territorial drug plans, with Product Listing Agreements expected to support broader patient access.
Addressing a Significant Need
Schizophrenia is a chronic psychiatric disorder that affects about 1% of the population and often emerges in late adolescence or early adulthood. More than 80% of patients relapse within five years of their first psychotic episode, often leading to hospitalization, worsening symptoms, and functional decline. Repeated relapses contribute to treatment resistance and long‑term impairment.
Long‑Acting Treatment Option
PrOKEDI delivers extended‑release risperidone through a once‑monthly injectable formulation. The therapy rapidly achieves therapeutic plasma concentrations and maintains drug exposure throughout the four‑week dosing interval without requiring oral supplementation or a loading dose. Unlike some long‑acting risperidone formulations, PrOKEDI can be initiated without oral risperidone overlap, offering a streamlined option for patients and clinicians.
Clinical Evidence
The pivotal Phase 3 PRISMA‑3 trial enrolled 438 adults experiencing acute exacerbations of schizophrenia. Both the 75 mg and 100 mg monthly doses produced statistically significant improvements in Positive and Negative Syndrome Scale (PANSS) total scores and Clinical Global Impression‑Severity (CGI‑S) scores compared with placebo (p<0.0001). Clinical response rates were consistently higher across symptom domains.
Safety outcomes were consistent with established risperidone experience, with common adverse events including prolactin‑related effects, headache, and weight gain. PrOKEDI achieved rapid symptom improvement in the pivotal trial and sustained disease stability in the 12‑month open‑label extension study, which enrolled 215 patients. No new safety signals were reported during long‑term treatment.
Expanding Access
Amy Cairns, General Manager of Bausch Health Canada, said the agreement moves PrOKEDI closer to broader public access for Canadians living with schizophrenia.
Dr. Howard Margolese, President of Early Psychosis Intervention Canada, welcomed the milestone as an important step toward expanding treatment options, while Dave Gallson, National Executive Director of the Mood Disorders Society of Canada, emphasized the importance of timely access to therapies that support long‑term stability and quality of life.
Access Pathway
With pCPA negotiations completed, Bausch Health will work with federal, provincial, and territorial drug plans to finalize reimbursement agreements. The pace of those discussions will determine how quickly eligible patients gain access, underscoring the growing role of long‑acting injectable antipsychotics in improving continuity of care for schizophrenia.
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About the Writer
Disha Sanjay Jadhao (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.