Most patients relapse within five years, and Bausch Health’s PrOKEDI targets that risk
Most people who experience a first episode of schizophrenia will relapse within five years, and each relapse can mean hospitalization, functional decline, and growing treatment resistance.
Bausch Health, Canada Inc. said a new long-acting injectable aimed at breaking that cycle has moved a step closer to public drug plan coverage.
The company said it has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) and reached a Letter of Intent for PrOKEDI (risperidone extended-release injectable suspension) 75mg and 100mg, an antipsychotic for treating schizophrenia in adults.
Bausch Health said the agreement moves the drug toward public coverage across Canada and that it will work with federal, provincial, and territorial drug plans to finalize Product Listing Agreements.
Bausch Health said over 80 percent of patients relapse within five years of a first episode, and that long-acting injectable antipsychotics may support treatment continuity and reduce relapse risk.
The company said PrOKEDI delivers risperidone over a four-week dosing interval without oral supplementation or a loading dose.
On clinical evidence, Bausch Health said the pivotal PRISMA-3 study (N=438) showed once-monthly PrOKEDI (75mg and 100mg) improved symptoms versus placebo over 12 weeks, with greater reductions in PANSS total and CGI-S scores reaching statistical significance (p<0.0001).
It said a 12-month open-label extension (N=215) showed sustained improvement and no new safety signals, with a safety profile consistent with known risperidone effects, including prolactin-related events, headache, and weight gain.
Bausch Health Canada agreed with the pan-Canadian Pharmaceutical Alliance to list PrOKEDI for schizophrenia on public drug plans, general manager Amy Cairns said.
She said the company would finalise the agreements before the drug becomes available.
Bausch Health said clinicians should establish tolerability with oral risperidone before starting PrOKEDI in patients new to the drug, and that Health Canada has not authorized PrOKEDI for patients under 18 years.
