Bausch Health Canada Announces Expanded Public Reimbursement for (Pr)OKEDI® (Risperidone for Extended-Release Injectable Suspension) Across Canada for the Treatment of Schizophrenia

Bausch Health Canada Announces Expanded Public Reimbursement for (Pr)OKEDI® (Risperidone for Extended-Release Injectable Suspension) Across Canada for the Treatment of Schizophrenia

LAVAL, QC, Oct. 19, 2026 /CNW/ -- Bausch Health, Canada Inc., a subsidiary of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), today announced expanded public reimbursement for ^PrOKEDI^® (extended-release injectable suspension of risperidone) 75 mg and 100 mg, with coverage now available for eligible patients, subject to the applicable reimbursement criteria, through public drug plans in seven provinces and multiple federal drug plans.

^PrOKEDI^® is now listed in Ontario, Quebec, British Columbia, Alberta, Saskatchewan, Nova Scotia and Prince Edward Island, as well as through federal drug plans administered by the Non-Insured Health Benefits Program (NIHB), Veterans Affairs Canada (VAC), the Department of National Defence (DND) and Correctional Service Canada (CSC). 

^PrOKEDI^® is a prolonged-release injectable suspension of risperidone indicated for the treatment of schizophrenia in adults.^{1 Pr}OKEDI^® is designed to provide rapid attainment of clinically relevant risperidone plasma concentrations, followed by sustained release over the four-week dosing interval, without the need for oral supplementation or a loading dose.¹

"Expanding public access to treatment options is central to how we support Canadians living with schizophrenia," said Amy Cairns, General Manager, Bausch Health, Canada Inc. "We are pleased that ^PrOKEDI^® is now accessible to eligible patients through public drug plans in seven provinces and through federal drug plans, and we remain committed to working with provinces and territories to further expand access across Canada."

"Broader reimbursement of ^PrOKEDI^®, the newest long-acting injection antipsychotic, is an important step forward for people living with schizophrenia. Long-acting injectable treatments can help reduce the risk of relapse, support continuity of treatment, and give patients greater opportunity to maintain stability and pursue their personal goals. Improving access to these treatments means putting more options in the hands of patients and clinicians to support long-term recovery and quality of life," said Dr. Tom Hastings, MD, FRCPC, Vice President, EPI Canada.

"For some people living with schizophrenia, long-acting injectable medications can be an important treatment option. Research suggests these treatments may support treatment continuity and help reduce some of the challenges associated with daily medication use," said Kayla Nicholls, Director of Programs and Impact, Institute for Advancements in Mental Health (IAMhealth). "Expanding public coverage helps reduce financial barriers and improves access to evidence-based treatment options for individuals and families."

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 course of schizophrenia and may be associated with worsening symptoms, hospitalization, functional decline and a more difficult course of illness, highlighting the importance of continuity of care.³ Although there is no cure for schizophrenia, the illness can be 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 relapse in patients living with schizophrenia.³

^PrOKEDI^® Clinical Data and Safety Information
In the pivotal PRISMA-3 randomized, double-blind, placebo-controlled study in adults experiencing an acute exacerbation of schizophrenia, 438 patients were randomized to receive once-monthly ^PrOKEDI^® 75 mg, ^PrOKEDI^® 100 mg or placebo for 12 weeks. Both ^PrOKEDI^® dose groups demonstrated statistically significant improvements from baseline in PANSS total score and CGI-S score compared with placebo at 12 weeks (p<0.0001). The most frequently reported treatment-emergent adverse events were increased blood prolactin, headache, hyperprolactinemia and weight increase. No new or unexpected relevant safety information was identified.⁴

In the 12-month open-label extension study (PRISMA-3 OLE; N=215), continued treatment with ^PrOKEDI^® was associated with sustained improvements in PANSS and CGI scores in patients who entered the study with unstable or stabilized disease, while symptom stability was generally maintained in patients who entered the study in the stable group. The long-term safety profile was consistent with that observed in the pivotal study, 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 

Please consult the Canadian Product Monograph for complete information regarding indications, contraindications, warnings, precautions, adverse reactions, dosage and administration.

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

1. Bausch Health Canada Inc. ^PrOKEDI^® Product Monograph. Revised December 5, 2025.
2. Ernest D, Vuksic O, Shepard-Smith A, Webb E. Schizophrenia: An Information Guide. Revised ed. Centre for Addiction and Mental Health; 2017.
3. Csernansky JG, Schuchart EK. Relapse and rehospitalisation rates in patients with schizophrenia: effects of second-generation antipsychotics. CNS Drugs. 2002;16(7):473–484; Kane JM. Treatment strategies to prevent relapse and encourage remission. J Clin Psychiatry. 2007;68(Suppl 14):27–30.
4. Correll CU, Litman RE, Filts Y, et al. Efficacy and safety of once-monthly Risperidone ISM^® in patients with schizophrenia experiencing an acute exacerbation. NPJ Schizophr. 2020;6:37.
5. Filts Y, Litman RE, Martínez J, et al. Long-term efficacy and safety of once-monthly Risperidone ISM^® in the treatment of schizophrenia: results from a 12-month open-label extension study. Schizophr Res. 2022;239:83–91.

SOURCE Bausch Health Companies Inc.