Québec is the first province to list (Pr)OKEDI(MC) (extended-release injectable suspension of risperidone) on the public drug reimbursement formulary for the treatment of schizophrenia

LAVAL, QC, July 6, 2026 /CNW/ -- Bausch Health, Canada Inc., a subsidiary of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), announces the listing of ^PrOKEDI^®  (extended-release injectable suspension of risperidone) 75 mg and 100 mg strengths to the drug formulary of the Régie de l'assurance maladie du Québec (RAMQ) effective June 25^th, 2026, for the treatment of schizophrenia in adults.

^PrOKEDI^® is a prolonged-release injectable suspension of risperidone indicated for the treatment of schizophrenia in adults. According to the Canadian product monograph, ^PrOKEDI^® achieves clinically relevant concentrations of the active ingredient within the first few hours after injection, without the need for a loading dose or oral supplementation. It provides sustained release over a 4-week dosing interval, without the need for oral supplementation or a loading dose.¹

This decision marks an important milestone in securing reimbursement for ^PrOKEDI^® in Quebec. This listing follows negotiations concluded earlier this year with the Pan-Canadian Pharmaceutical Alliance (APP). Bausch Health will continue its efforts with other provincial jurisdictions in accordance with their respective reimbursement processes.

"This decision confirms the importance in providing timely access to innovative mental health treatments," said Amy Cairns, General Manager, Bausch Health, Canada Inc. "By making ^PrOKEDI^® accessible, Québec is concretely improving the range of therapeutic options available to people living with schizophrenia."

"The reimbursement of ^PrOKEDI^® is excellent news. It provides psychiatrists and healthcare teams with an additional effective treatment option for patients, both in hospitals and in the community," said Dr Tin Ngo-Minh, MD, FRCPC.

"The Québec Schizophrenia Society (SQS) welcomes the arrival of a new medication that is now accessible to people living with schizophrenia in Québec. Because each journey is unique and needs vary from one individual to another, it is essential that patients and their care teams have access to a range of treatment options. Each new medication represents another opportunity for individuals living with the condition to find a treatment that truly supports their recovery journey. For many individuals and families, increased access to therapeutic choices also brings hope and opens the door to new possibilities for well-being and stability," said Denis Tremblay, Director, Schizophrenia Society of Québec.

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 PRISMA-3 pivotal study, a randomized, double-blind, placebo-controlled trial conducted in adults with an acute exacerbation of schizophrenia (N=438), demonstrated that OKEDI, administered once a month (75 mg and 100 mg), significantly improved symptoms compared with placebo over 12 weeks. Treatment resulted in greater reductions in total PANSS and CGI-S scores, with statistically significant differences (p<0.0001). Improvements were also observed in the positive and negative symptom subscales, and overall response rates were higher with OKEDI than with placebo. The safety profile was consistent with that known for risperidone, with the most common adverse events related to prolactin, headache, and weight gain. ⁴

In the 12-month open-label extension study (PRISMA-3 OLE; N=215), continued treatment with OKEDI was associated with maintenance of the observed clinical improvements. The long-term safety profile was consistent with that observed in the pivotal study, with no new safety signals. ⁵

In patients who have never taken risperidone, tolerance to oral risperidone must be established before starting treatment with OKEDI. OKEDI is indicated for the treatment of schizophrenia in adults.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, Québec, 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 (dated December 5, 2025)
2. Schizophrenia: An Information Guide – Center for Addiction and Mental Health. 2017. schizophrenia-guide-en.pdf
3. Csernansky & Schuchart. CNS Drugs. 2002;16(7):473–484; Kane. J Clin Psychiatry. 2007;68(Suppl 14):27–30
4. Efficacy and safety of once-monthly Risperidone ISM^® in schizophrenic patients with an acute exacerbation. Correll at al. 2020.
5. 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.

BHC-PRODUCTS

SOURCE Bausch Health Companies Inc.

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