Bausch Health Canada Inc. announced that PrOKEDI risperidone extended-release injectable suspension in 75 mg and 100 mg strengths has secured expanded public reimbursement across seven Canadian provinces and multiple federal drug plans for adult schizophrenia patients.
PrOKEDI Provincial Reimbursement Scope
- PrOKEDI 75 mg and 100 mg are now covered under public drug plans in Ontario, Quebec, British Columbia, Alberta, Saskatchewan, Nova Scotia, and Prince Edward Island.
- Bausch Health Companies Inc. shares (BHC) traded up 1.16% at $6.38.
Expanded Public Drug Plan Coverage Across Seven Provinces
Adults living with schizophrenia in seven Canadian provinces now have public drug plan access to PrOKEDI risperidone extended-release injectable suspension in 75 mg and 100 mg doses. Alongside provincial inclusion in Ontario, Quebec, British Columbia, Alberta, Saskatchewan, Nova Scotia, and Prince Edward Island, federal programs have integrated the treatment.
Bausch Health Canada Inc., a subsidiary of Bausch Health Companies Inc., stated that the broader reimbursement aims to widen access to long-acting injectable therapy and ease financial barriers to ongoing care.
Clinical Trial Results and Dosing Profile Details
PrOKEDI functions as a long-acting injectable formulation engineered to deliver clinically relevant risperidone concentrations. It maintains sustained release over a four-week dosing interval without requiring oral supplementation or an initial loading dose.
The pivotal Phase 3 PRISMA-3 study evaluated the medication in 438 adults dealing with an acute exacerbation of schizophrenia. Both the 75 mg and 100 mg strengths demonstrated statistically significant improvements in Positive and Negative Syndrome Scale total scores and Clinical Global Impression-Severity scores compared with a placebo group at 12 weeks.
| Study Metric | PRISMA-3 Trial Findings |
|---|---|
| Patient Cohort | 438 adults experiencing an acute exacerbation of schizophrenia | Evaluation Period | 12 weeks |
| Primary Efficacy Measures | Statistically significant improvements in PANSS total scores and CGI-S scores vs. placebo |
| Dosing Parameters | 75 mg and 100 mg over a four-week interval without oral supplementation or loading dose |
| Reported Adverse Events | Increased blood prolactin, headache, hyperprolactinemia, and weight increase |
Safety Data and Financial Market Response
The most frequently documented treatment-emergent adverse events during evaluation included increased blood prolactin, headache, hyperprolactinemia, and weight increase. Company statements confirmed no new or unexpected relevant safety signals emerged during the observation period.
Bausch Health Companies Inc. shares (BHC) traded up 1.16% at $6.38.
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