Ms. Amy Cairns reports

QUEBEC 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

Bausch Health Canada Inc., a subsidiary of Bausch Health Companies Inc., has listed PrOKEDI (extended-release injectable suspension of risperidone) 75-milligram and 100 mg strengths to the drug formulary of the Regie de l'assurance maladie du Quebec (RAMQ) effective June 25, 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 four-week dosing interval, without the need for oral supplementation or a loading dose.

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. "By making PrOKEDI accessible, Quebec 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 health care teams with an additional effective treatment option for patients, both in hospitals and in the community," said Dr. Tin Ngo-Minh, MD, FRCPC.

"The Quebec Schizophrenia Society (SQS) welcomes the arrival of a new medication that is now accessible to people living with schizophrenia in Quebec. 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 Quebec.

About schizophrenia

Schizophrenia is a chronic and severe psychiatric disorder that typically emerges in late adolescence or early adulthood and affects about 1 per cent 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.

Relapses are common throughout the illness, with over 80 per cent of patients experiencing relapse within five years of a first episode of schizophrenia. 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 equals 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 less than 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.

In the 12-month open-label extension study (PRISMA-3 OLE; N equals 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.

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.

About Bausch Health Companies Inc.

Bausch Health is a global, diversified pharmaceutical company enriching lives through the company's relentless drive to deliver better health outcomes. The company develops, manufactures and markets a range of products primarily in gastroenterology, hepatology, neuroscience, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through the company's controlling interest in Bausch + Lomb Corp. Its ambition is to be a globally integrated health care company, trusted and valued by patients, HCPs (health care professionals), employees and investors.

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