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Launch of Tiopronin Delayed-Release Tablets with Patient Support for Cystinuria Treatment in the United States

Tuesday, May 14, 2024

Cycle Pharmaceuticals Limited (Cycle) is excited to introduce tiopronin delayed-release tablets as a treatment option for individuals with cystinuria. Tiopronin delayed-release tablets come in 100 mg and 300 mg doses and have received approval from the US Food and Drug Administration (FDA).1 These tablets must be taken without food.

Cystinuria, the most common hereditary cause of kidney stone disease, affects approximately 1 in 7,000 people worldwide.2

The launch of tiopronin delayed-release tablets is a collaborative effort between Cycle, Torrent Pharma Inc. (Torrent), and Anovo Specialty Pharmacy (Anovo). Together, these companies are dedicated to providing patients with rare diseases access to necessary medications and support services.

Tiopronin delayed-release tablets are accompanied by Cycle Vita™, a dedicated support platform offering personalized product support* for patients. Anovo, the exclusive specialty pharmacy for this product, provides ongoing dispensing and support services.

Chikai Lai, Cycle's SVP & Chief Commercial Officer, emphasizes the chronic nature of cystinuria and the challenges patients face in managing it effectively. To address these challenges, Cycle offers individualized support programs such as the Bridge Program* and Co-pay Assistance Program*, along with a Patient Nutrition Program* to complement clinical nutrition plans.

Tiopronin delayed-release tablets mark Cycle's fifth commercial product launch in the US, following the introduction 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.

Indicated for use in combination with high fluid intake, alkali, and diet modification, tiopronin delayed-release tablets are intended to prevent cystine stone formation in adults and pediatric patients aged 9 years and older with severe homozygous cystinuria who do not respond adequately to these measures alone.1

INDICATIONS

Tiopronin delayed-release tablets are 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.

WARNINGS AND PRECAUTIONS

Tiopronin use has been associated with proteinuria, including nephrotic syndrome, and membranous nephropathy. Pediatric patients receiving more than 50 mg/kg of tiopronin per day may be at increased risk of proteinuria.

Hypersensitivity reactions, including drug fever, rash, fever, arthralgia, and lymphadenopathy, have been reported.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions (≥10%) include nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and vomiting.

DRUG INTERACTIONS

Alcohol may affect the release of tiopronin from delayed-release tablets, but the risk of adverse events when tiopronin is taken with alcohol is unknown. Patients should avoid alcohol consumption for 2 hours before and 3 hours after taking tiopronin delayed-release tablets.

USE IN SPECIFIC POPULATIONS:

Pregnancy: Available data from published case reports have not identified a significant risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with tiopronin use during pregnancy. However, renal stones in pregnancy may lead to adverse outcomes. Patients should inform their healthcare provider immediately if they become pregnant or are planning to become pregnant.

Lactation: There are no data on the presence of tiopronin in human or animal milk or its effects on breastfed infants. Tiopronin may inhibit milk production, and breastfeeding is not recommended during treatment. Patients should inform their healthcare provider immediately if they plan to breastfeed.

Pediatric Use: Tiopronin delayed-release tablets are indicated for pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation. They are not approved for use in pediatric patients weighing less than 20 kg or unable to swallow tablets.

Geriatric Use: Elderly patients may have impaired renal function, increasing the risk of adverse reactions. Dose selection should be cautious, and renal function monitoring may be beneficial.

Cycle Vita™, SAJAZIR™, and JAVYGTOR™ are trademarks of Cycle Pharmaceuticals Limited in the United States. NITYR® is a registered trademark of Cycle Pharmaceuticals Limited in the United States. TASCENSO ODT® is a registered trademark of Handa Neuroscience, LLC.

 

Source: businesswire.com

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