New US product launch, VENXXIVA™ (tiopronin) Delayed-Release Tablets for the treatment of cystinuria

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BOSTON– Cycle Pharmaceuticals Limited (Cycle) announced today the launch of VENXXIVA (tiopronin) Delayed-Release Tablets, for the treatment of cystinuria, approved by the US Food and Drug Administration (FDA). VENXXIVA is launched in partnership between Cycle and Torrent Pharma Inc. (Torrent), and exclusive distribution partner, Vanscoy Rare Pharmacy (Vanscoy Rare).

Affecting approximately 1 in 7,000 people worldwide, cystinuria is a rare condition in which the amino acid cysteine forms stones in the urinary system. VENXXIVA is a treatment option for patients with cystinuria who want to benefit from the patient support services provided by Cycle Vita™. Through Cycle Vita, eligible* patients will have access to financial, product and clinical education programs tailored to their needs.

VENXXIVA follows on from the successful launch of Cycle and Torrent’s generic tiopronin delayed-release tablets in March 2024. Cycle Vita and Vanscoy Rare will actively work with patients and clinics to support the transition of patients prescribed with generic tiopronin delayed-release tablets to VENXXIVA, and continue their access to Cycle Vita’s patient support services.

“One in five patients taking tiopronin have reported missing doses on a daily basis. If improvements in tiopronin adherence can be achieved, along with diet modifications for low salt and high fluid intake, there is a possibility for a greater health-related quality of life. At Cycle, we understand that rare disease patients need additional support to manage their condition. That’s why we’re providing individualized support for patients with cystinuria, including dietary and nutritional support,” says Jamie Ray, Director – Patient Support Program, Cycle.

VENXXIVA (tiopronin) Delayed-Release Tablets must be taken without food and are available in 100 mg and 300 mg doses. The VENXXIVA 300 mg Delayed-Release Tablet may provide a convenient reduction in pill burden for patients.

VENXXIVA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adult and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.

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