Cystinuria

MALVERN, Pa., July 15, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of tiopronin delayed-release tablets, a generic version of Travere Therapeutics' THIOLA EC®. "We're proud to provide high-quality, affordable choices to healthcare providers and their appropriate patients," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions & Generics. "The launch of tiopronin delayed-release tablets strengthens our generic product portfolio and underscores our reputation as a reliable supplier." The medication is used in combination with high fluid intake, alkali (low acid), and dietary changes to help prevent the formation of one type (cystine) of kidney stones in certain adult and pediatric patients. As a demonstration of its commitment to patients, Endo is offering copay assistance for those who meet eligibility requirements. To learn more about Endo's Patient Assistance Program, patients can call (833) 727-4357. THIOLA EC® is a registered trademark of Mission Pharmacal Company. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Tiopronin delayed-release tablets are contradicted in patients with hypersensitivity to tiopronin or any other components of tiopronin delayed-release tablets. WARNINGS AND PRECAUTIONS Proteinuria Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. Monitor patients for the development of proteinuria and discontinue therapy in patients who develop proteinuria. Hypersensitivity Reactions Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported. ADVERSE REACTIONS Most common adverse reactions (≥ 10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis. DRUG INTERACTIONS Alcohol Tiopronin is released faster from tiopronin delayed-release tablets in the presence of alcohol and the risk for adverse events associated with tiopronin delayed-release tablets when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking tiopronin delayed-release tablets. USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended during treatment with tiopronin delayed-release tablets. Pediatric Use: Tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg. Geriatric Use: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. INDICATIONS AND USAGE 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. Please click for full Prescribing Information. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Mr. Sims and any statements relating to Endo's product launch, quality, affordability, efficacy, reliability or sales. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, changes in competitive, market or regulatory conditions, and consumer and physician acceptance of current and new products. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. SOURCE Endo, Inc.

BOSTON--(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 or call +1 (888) 360-8482 and find the Full Prescribing Information available at . Important Safety Information Important Safety Information is below. Full Prescribing Information is available at . INDICATIONS Tiopronin delayed-release tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for 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 Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported. MOST COMMON ADVERSE REACTIONS Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis. DRUG INTERACTIONS Alcohol: Tiopronin is released faster from tiopronin delayed-release tablets in the presence of alcohol and the risk for adverse events associated with tiopronin delayed-release tablets when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking tiopronin delayed-release tablets. USE IN SPECIFIC POPULATIONS: Pregnancy: Available published case report data with tiopronin have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Renal stones in pregnancy may result in adverse pregnancy outcomes. Tell your healthcare provider immediately if you become pregnant or planning to become pregnant. Lactation: There are no data on the presence of tiopronin in either human or animal milk or on the effects of the breastfed child. A published study suggests that tiopronin may suppress milk production. Because of the potential for serious adverse reactions, including nephrotic syndrome, advise patients that breastfeeding is not recommended during treatment with tiopronin delayed-release tablets. Tell your healthcare provider immediately if you plan on breast feeding. Pediatric Use: Tiopronin delayed-release tablets are indicated in 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 who are not responsive to these measures alone. Tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg or in pediatric patients unable to swallow tablets. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. For more detailed information, please refer to the full Prescribing Information at . If you get any side effects, talk to your healthcare provider. This includes possible side effects not listed in this material. You may also report side effects directly by calling Torrent Pharma Inc. at: 1-800-912-9561 or FDA at: 1-800-FDA-1088 or . This material is for education purposes only. It is not intended to be, and should not be used as, a substitute for medical advice. US-TIO-2400004 (February 2024) References Tiopronin Delayed-Release Tablets. Prescribing Information. Torrent Pharma Inc. Leslie, S.W., Sajjad, H. and Nazzal, L. (2023). Cystinuria. [online] Nih.gov. Available at: [Accessed Feb 9 2024]. Cystinuria UK - Diet - what should I eat (2023). Cystinuria UK - Diet - what should I eat? [online] Cystinuriauk.co.uk. Available at: [Accessed Feb 9 2024]. * Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at +1 (888) 360-8482. The US Prescribing Information provides the indications for which the product is approved in the US. Please consult the US Prescribing Information and product labeling for information about the specific uses for which the product is indicated in the US. –ENDS– 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. ©2024 Cycle Pharmaceuticals Limited. All rights reserved. About Cycle Pharmaceuticals Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease patient community. Cycle focuses on rare metabolic, immunological, and neurological genetic conditions. Within neurological conditions, we focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit and follow us on X, LinkedIn and Facebook. About Torrent Pharma Inc. Torrent Pharma is one of the leading Pharma companies in India. Torrent is the pioneer in initiating the concept of niche marketing in India and today is ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC). Torrent also has significant presence in diabetology, pain management, gynecology, oncology and anti-infective segments. Torrent Pharma is present in more than 40 countries. It is ranked first amongst Indian Companies for having largest market share in Brazil and Germany. About Anovo Anovo was founded in 2012 as an exclusive provider of comprehensive end-to-end services for manufacturers of rare disease drugs and patients who need the drugs, including specialty wholesale/3PL distribution services, specialty pharmacy services, and patient support hub programs. Anovo benefits all parties involved by navigating all the complexities of managing rare disease medications and providing the related support needed by patients, caregivers and prescribers. View source version on businesswire.com: Contacts Marketing@cyclepharma.com Cycle Pharmaceuticals Tel: +44 1223 354 118 Source: Cycle Pharmaceuticals Limited View this news release online at:

Shares in Synlogic cratered Thursday, sinking as much as 55% in after-hours trade following the company's decision to pull the plug on a Phase III study of its lead asset labafenogene marselecobac (SYNB1934) as a potential treatment for phenylketonuria.The company is now weighing a menu of options for its future, including a possible acquisition, merger, sale of assets or dissolution, but in the meantime is closing down operations, and laying off almost all of its staff. The majority of impacted positions will end this month. About 10% of workers will be retained to help with its strategic review and assist in the discontinuation of the Synpheny-3 study.Synpheny-3 got under way last June, and Synlogic noted at the time that it incorporated feedback regarding its design from global regulatory agencies, including the FDA. The global study was expected to recruit approximately 150 patients with baseline plasma phenylalanine (Phe) levels of >360 μM, and tested three doses. The primary endpoint was change in plasma Phe levels.Trial unlikely to succeedHowever, an internal review conducted in advance of an upcoming independent data monitoring committee (DMC) assessment, indicated the trial was unlikely to meet its primary endpoint. Synlogic said its decision was not based on any safety or tolerability concerns. Labafenogene marselecobac is a synthetic biotic designed from natural probiotic single strain bacteria engineered using Synlogic's synthetic biology and microbiome platform.The company's other pipeline projects include SYNB1353 and SYNB8802, both at the cusp of entering Phase II for classical homocystinuria and enteric hyperoxaluria, respectively, according to its website. It was also working on the preclinical gout treatment SYNB2081, and two other undisclosed candidates for cystinuria and inflammatory bowel disease.