Ioflupane-I-123

ST. LOUIS, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that beginning Friday, April 5, 2024, Ioflupane I 123 Injection will be available for Friday patient administration in the US. This additional day of production allows customers to access the product and capitalize on early morning availability on a day not previously available from Curium. Ioflupane I 123 Injection is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Customers may begin ordering for Friday patient use immediately for administration on and after April 5, 2024. This expansion in capacity should help address a growing need for SPECT brain imaging. Approximately 90,000 people in the US each year are diagnosed with Parkinson’s1 and nearly 1.24 million will be diagnosed by 20302. Additionally, one in four patients with dementia suffers from DLB, making it the second most common form of degenerative dementia after Alzheimer’s Disease3. The clinical signs and symptoms of DLB can be atypical and overlap with other forms of dementia, leading to up to 70% of patients with DLB being misdiagnosed, often as having Alzheimer’s Disease4. Robert Burke, North American Senior Vice President of Commercial at Curium, commented: “Curium’s expanded capacity on Fridays will allow our customers and their patients greater scheduling flexibility. Our customers have asked for this expansion and Curium is thrilled to be able to satisfy this request. We look forward to launching Friday patient use on April 5.” About Ioflupane I 123 Injection INDICATION AND USE Ioflupane I 123 is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Important Risk Information CONTRAINDICATIONS Ioflupane I 123 Injection is contraindicated in patients with known serious hypersensitivity to Ioflupane I 123. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following Ioflupane I 123 Injection administration. Thyroid Accumulation: The Ioflupane I 123 Injection may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of I-123, block the thyroid gland before administration of Ioflupane I 123 Injection. Radiation Risk: Ioflupane I 123 Injection emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients. ADVERSE REACTIONS In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported. DRUG INTERACTIONS Drugs that bind to the dopamine transporter with high affinity may interfere with the Ioflupane I 123 Injection image. The impact of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging results has not been established. USE IN SPECIFIC POPULATIONS Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of Ioflupane I 123 Injection in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on Ioflupane I 123 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risks of fetal exposure to radiation with the administration of Ioflupane I 123 Injection. Lactation: Iodine 123 (I 123), the radionuclide in Ioflupane I 123 Injection, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after Ioflupane I 123 Injection administration to minimize radiation exposure to a breastfeeding infant. Pediatric Use: The safety and efficacy of Ioflupane I 123 Injection have not been established in pediatric patients. Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment observed in the parkinsonian syndrome studies. Renal Impairment: Ioflupane I 123 Injection is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered Ioflupane I 123 Injection images. OVERDOSAGE The risks of overdose relate predominantly to increased radiation exposure, with the long-term risk for neoplasia. In case of overdosage of radioactivity, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. Please see full Prescribing Information by clicking here or visit References: 1 Willis AW, Roberts E, Beck JC, et al. “Incidence of Parkinson disease in North America.” NPJ Parkinsons Disease. 2022;8:170. 2 Marras C, Beck JC, Bower JH, et al. “Prevalence of Parkinson’s disease across North America.” NPJ Parkinsons Disease. 2018;4:21. doi:10.1038/s41531-018-0058-0 3 Barker, Warren W, Luis, Cheryl A, Kashuba A, et al. “Relative frequencies of Alzheimer disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank.” Alzheimer Disease and Associated Disorders vol. 16,4 (2002): 203-12. doi:10.1097/00002093-200210000-00001 4 Warr L, Walker Z. “Identification of biomarkers in Lewy-body disorders.” Quarterly Journal of Nuclear Med Mol Imaging; 2012; 56: 39-54 About Curium Curium is a world leader in nuclear medicine. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Ross Bethell ross.bethell@curiumpharma.com or +44.7827.833.176.

A new framework has been established by leading scientists and patient organisations for using two tests to improve clinical trials for identifying Parkinson’s disease (PD). Affecting around 145,000 people in the UK, PD is a progressive neurological condition that affects the brain, causing symptoms such as shaking and stiffness. The new staging framework, published in The Lancet , proposes how two important medical tests could be used in clinical trials of new treatments for Parkinson’s, as well as other related conditions, and have been selected for their ability to identify key biological features of the disease. The framework involved experts from the Center for Drug Evaluation and Research, the Michael J Fox Foundation for Parkinson’s Research, Swiss pharmaceutical company Roche, Parkinson’s UK and Cure Parkinson’s. A major challenge faced within clinical trials for PD is that most diagnoses are based on symptoms, which can differ from person to person. By having tests that can identify what exactly is occurring inside the brain, clinical trials for PD will be more able to select the right participants and will be better able to measure the potential of the treatment under investigation. The first test selected can identify misfolded alpha-synuclein, a protein that is a hallmark of PD, from fluid taken from the spine via a lumbar puncture test. The second test is a brain scan known as DaTSCAN, which can identify whether there is a lack of dopamine, a chemical that progressively decreases over time in PD, within the brain. Both tests identify people who are in the early stages of the disease before obvious symptoms emerge. Ultimately, this will speed up the development of therapies that can stop the loss of brain cells in the disease, which, at present, no treatments have achieved. Helen Matthews, chief executive officer at Cure Parkinson's, commented: “Adding precision to our clinical trials is vital” and “would be a big step forward… to gain clearer answers evaluated on biology rather than clinical assessments”.