LAVAL, QC, June 9, 2026 /CNW/ -- Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC), today announced that it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA), resulting in a Letter of Intent (LOI) for PrOKEDI® (Risperidone extended-release injectable suspension) 75mg and 100mg, a long-acting injectable antipsychotic agent for the treatment of schizophrenia in adults.1
The issuance of this LOI marks a key milestone toward securing public coverage and enabling patient access to PrOKEDI® across Canada. Bausch Health remains committed to working closely with federal, provincial, and territorial public drug plans, to finalize Product Listing Agreements and support timely and equitable access for Canadians living with schizophrenia.
PrOKEDI® is designed to provide rapid attainment of clinically relevant risperidone plasma concentrations, followed by sustained release over the 4‑week dosing interval, without the need for oral supplementation or a loading dose.1
"We are very pleased to have reached agreement with the pan-Canadian Pharmaceutical Alliance on terms that will help expand access to PrOKEDI® for people living with schizophrenia through public drug plans," said Amy Cairns, General Manager, Bausch Health, Canada Inc. "This milestone brings us closer to supporting patients, their families, and caregivers with new treatment options, and we look forward to quickly finalizing agreements so Canadians can benefit as soon as possible."
"We welcome the Letter of Intent between Bausch Health, Canada Inc. and pCPA, which will advance access to PrOKEDI® and providing people living with schizophrenia with an important new treatment option." Dr. Howard Margolese, MD, CM, MSc, FRCPC, President of Early Psychosis Intervention Canada
"It is very encouraging to see progress toward improved access to medications for Canadians living with schizophrenia," said Dave Gallson, National Executive Director of Mood Disorders Society of Canada. "Schizophrenia is a life changing illness that can profoundly affect daily functioning, independence, and quality of life, making timely access to additional treatment options critical to helping people living with schizophrenia lead more stable, fulfilling lives."
About Schizophrenia
Schizophrenia is a chronic and severe psychiatric disorder that typically emerges in late adolescence or early adulthood and affects about 1% of the population. The illness is characterized by episodes of psychosis and loss of contact with reality, as well as emotional and cognitive symptoms. It affects how a person thinks, feels, behaves, and relates to others, often impairing functioning, relationships, employment and quality of life.2
Relapses are common throughout the illness, with over 80% of patients experiencing relapse within five years of a first episode of schizophrenia.3 Relapse is associated with progressive brain loss, worsening symptoms, hospitalization, functional decline and increasing treatment resistance, highlighting the importance of early intervention, sustained symptom control and continuity of care. Although there is no cure for schizophrenia, the illness can be effectively managed through a combination of antipsychotic medication, psychosocial support, and community-based care, enabling many people to achieve stability, recovery, and meaningful participation in daily life.2
Long-acting injectable antipsychotics may play an important role in supporting treatment continuity and reducing the risk of relapses in patients living with schizophrenia.
OKEDI Clinical Data and Safety Information
The pivotal PRISMA‑3 randomized, double‑blind, placebo‑controlled study in adults with acute exacerbation of schizophrenia (N=438) demonstrated that once‑monthly PrOKEDI® (75 mg and 100 mg) significantly improved symptoms versus placebo over 12 weeks. Treatment resulted in greater reductions in PANSS total scores and CGI‑S scores, with differences versus placebo reaching statistical significance (p<0.0001). Improvements were also observed across symptom domains. In the published study, higher response rates were observed with PrOKEDI® compared to placebo. The safety profile was consistent with known risperidone effects, including prolactin‑related events, headache, and weight gain.4
In the 12‑month open‑label extension study (PRISMA‑3 OLE; N=215), continued treatment with PrOKEDI® was associated with sustained symptom improvement and disease stability. The long‑term safety profile was consistent with that observed in the pivotal trial, with no new safety signals identified.5
For patients who have never taken risperidone, tolerability with oral risperidone prior to initiating treatment with PrOKEDI® should be established. Health Canada has not authorized the use of PrOKEDI® in pediatric patients (<18 years).1
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neuroscience, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, chronic weight management, allergy, neuropsychiatry and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found on the Company's website at www.bauschhealth.ca.
Forward-looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
REFERENCES
- Bausch Health, Canada Inc. PrOkedi® Product Monograph (dated December 5, 2025)
- Schizophrenia: An Information Guide – Center for Addiction and Mental Health. 2017. schizophrenia-guide-en.pdf
- Csernansky & Schuchart. CNS Drugs. 2002;16(7):473–484; Kane. J Clin Psychiatry. 2007;68(Suppl 14):27–30
- Efficacy and safety of once-monthly Risperidone ISM® in schizophrenic patients with an acute exacerbation. Correll at al. 2020.
- Long-term efficacy and safety of once-monthly Risperidone ISM® in the treatment of schizophrenia: Results from a 12-month open-label extension study. Filts et al. 2022.
SOURCE Bausch Health Companies Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2026/09/c5628.html