New tiopronin delayed-release tablets launch with patient support for the treatment of cystinuria in the US
BOSTON, May 13, 2024–(BUSINESS WIRE)–Cycle Pharmaceuticals Limited (Cycle) is pleased to announce the launch of tiopronin delayed-release tablets as a treatment option for patients with cystinuria.1 Tiopronin delayed-release tablets are available in 100 mg and 300 mg doses, and are approved by the US Food and Drug Administration (FDA).1 Generic tiopronin delayed-release tablets must be taken without food.1
Cystinuria is the most common inheritable cause of kidney stone disease. Incidence of the condition is estimated to be 1 in 7,000 worldwide.2
The launch of tiopronin delayed-release tablets is a partnership between Cycle and Torrent Pharma Inc. (Torrent) utilizing Anovo Specialty Pharmacy (Anovo) in which all three companies are committed to providing patients with rare diseases the medication and patient support they need.
Tiopronin delayed-release tablets are a treatment option for patients with cystinuria who want to benefit from the support services provided by Cycle Vita™, a dedicated support platform which provides individualized product support* for patients, and ongoing dispensing and support services provided by Anovo, the exclusive specialty pharmacy for this product.
“Cystinuria is a chronic lifelong condition in which stones commonly reoccur.3 In addition, close control of a patient’s diet, specifically a reduction in salt and methionine intake, can have an impact on the likelihood of stones forming.3 We are fully aware of the unique personal challenges these patients face in effectively managing their cystinuria. That’s why we’re providing individualized support including a Bridge Program* and Co-pay Assistance Program*. In addition, a Patient Nutrition Program* will be available to reinforce the clinic’s nutrition plan,” says Chikai Lai, SVP & Chief Commercial Officer, Cycle.
Tiopronin delayed-release tablets are Cycle’s fifth commercial product to be launched in the US, building on the launch of:
NITYR® (nitisinone) Tablets in 2017
SAJAZIR™ (icatibant) Injection in 2021
JAVYGTOR™ (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution in 2022; and
TASCENSO ODT® (fingolimod) in 2023
Tiopronin delayed-release tablets are indicated in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Tiopronin delayed-release tablets must be taken without food.1
To find out more about Cycle Vita, please visit www.cyclevita.life or call +1 (888) 360-8482 and find the Full Prescribing Information available at www.tiopronin.us/PI.