Viatris Inc. announced the launch of Gen-Clozapine orally disintegrating tablets (ODT) in Canada, providing the first orally disintegrating formulation of clozapine available in the country. The medication is indicated for treatment-resistant schizophrenia and is available in five dosage strengths: 12.5 mg, 25 mg, 50 mg, 100 mg, and 200 mg.
Addressing Treatment-Resistant Schizophrenia
Clozapine represents the only approved antipsychotic medication for treatment-resistant schizophrenia, a condition affecting an estimated 25% to 30% of individuals with schizophrenia. The new orally disintegrating formulation offers an alternative administration method for patients who may benefit from this delivery system.
Dr. Ofer Agid, Medical Head of Ambulatory Services in the Schizophrenia Division at the Centre for Addiction and Mental Health (CAMH) in Toronto, emphasized the clinical significance of this development. "The introduction of Gen-Clozapine is welcome news for patients and physicians alike as this new clozapine formulation rapidly disintegrates when placed on the tongue or can be chewed, which provides a new option for some patients who may need it," Dr. Agid stated. "This also gives physicians an alternative to the current tablet dosage form."
Established Treatment Platform
Viatris has maintained a presence in the Canadian clozapine market since 2003, when Gen-Clozapine first became available in traditional tablet form. The company has provided access to this medication through the Gen-Clozapine Access Network (GenCAN) for over 18 years, supporting thousands of Canadian patients.
Jeffrey Long, Viatris Canada's Country Manager, highlighted the company's commitment to expanding treatment options. "The launch of Gen-Clozapine orally disintegrating tablets demonstrates further evidence of our commitment to providing diversified treatment options to patients and healthcare professionals in Canada," Long commented. "Viatris' strong heritage in mental health, and experience with clozapine specifically, puts us in an excellent position to provide access to this new formulation which will impact patient treatment."
Patient Support and Access
The orally disintegrating tablets are available by prescription only through the GenCAN patient support program. This comprehensive program focuses on patient safety, clinical knowledge advancement, and technology solutions to simplify monitoring practices. GenCAN currently supports more than 12,000 active patients across Canada, working collaboratively with healthcare teams to ensure safe and effective use of Gen-Clozapine.
The program's extensive reach demonstrates the significant patient population requiring clozapine therapy for treatment-resistant schizophrenia. Through GenCAN, Viatris provides ongoing support for monitoring practices essential for clozapine administration, given the medication's unique safety profile and monitoring requirements.
