Bausch Health, Canada Inc. announced a Letter of Intent with the pan-Canadian Pharmaceutical Alliance for public drug plan coverage of PrOKEDI (risperidone extended-release injectable suspension) for the treatment of schizophrenia in adults. The agreement marks a significant milestone toward securing public coverage and expanding patient access across Canada.
PrOKEDI is a long-acting injectable antipsychotic designed to provide rapid attainment of clinically relevant risperidone plasma concentrations, followed by sustained release over a four-week dosing interval, without the need for oral supplementation or a loading dose. Amy Cairns, General Manager of Bausch Health, Canada Inc., stated the milestone brings the company closer to supporting patients, families, and caregivers with new treatment options.
Schizophrenia affects approximately 1 percent of the population and typically emerges in late adolescence or early adulthood. The chronic psychiatric disorder is characterized by episodes of psychosis and loss of contact with reality, along with emotional and cognitive symptoms. Over 80 percent of patients experience relapse within five years of a first episode, which carries significant consequences including progressive brain loss, worsening symptoms, hospitalization, functional decline, and increasing treatment resistance.
The pivotal PRISMA-3 randomized, double-blind, placebo-controlled study in 438 adults with acute exacerbation of schizophrenia demonstrated that once-monthly PrOKEDI significantly improved symptoms versus placebo over 12 weeks. Treatment resulted in greater reductions in PANSS total scores and Clinical Global Impression-Severity scores, with differences versus placebo reaching statistical significance. Higher response rates were observed with PrOKEDI compared to placebo. A 12-month open-label extension study with 215 participants showed continued treatment was associated with sustained symptom improvement and disease stability. The safety profile was consistent with known risperidone effects, including prolactin-related events, headache, and weight gain, with no new safety signals identified in the long-term study. Long-acting injectable antipsychotics may play an important role in supporting treatment continuity and reducing relapse risk in patients living with schizophrenia.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/bausch-health-canada-inc-and-the-pan-canadian-pharmaceutical-alliance-sign-letter-of-intent-for-public-drug-plan-coverage-of-prokedi-risperidone-for-extended-release-injectable-suspension-for-the-treatment-of-schizophrenia