2023-10-18 18:46:16
MYSIMBA® shows no increased risk of serious adverse cardiac events in a large, long-term real-world evidence study
Brentwood, Tennessee (ots/PRNewswire) – Currax Pharmaceuticals LLC (“Currax”) today announced the initial results of a Cardiovascular Health Outcomes Analysis (HOA). This study evaluated the cardiovascular safety of CONTRAVE®/MYSIMBA®, a weight management medication. The real-world study evaluated CONTRAVE®/MYSIMBA ® compared to a similar product to measure major adverse cardiovascular events (MACE). The primary analysis included over 24,600 patients with an average follow-up of over 1,700 days.
Researchers found no evidence of increased cardiovascular risk and no statistically significant difference in the incidence of MACE between the CONTRAVE®/MYSIMBA® group and the comparison group. The HOA results are consistent with four prior randomized clinical trials and more than nine years of post-marketing safety monitoring data covering over 600,000 patient-years of product use. These results contribute to further understanding of the cardiovascular safety profile of CONTRAVE®/MYSIMBA®.
“We are pleased with the results of this cardiovascular health outcomes analysis, which includes long-term follow-up of patients prescribed CONTRAVE®/MYSIMBA®,” noted Dr. Michael Kyle, Currax SVP, Chief Medical Officer. “We plan to complete the full Study report will be submitted to both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the coming days; full results of the HOA study will be forthcoming published in a scientific publication.”
“We began this important safety study almost two years ago with the support of leading experts in real-world evidence analysis. “I am pleased with the outcome and what it means for patients taking CONTRAVE®/MYSIMBA®,” said George Hampton, President and CEO of Currax. “I am grateful to everyone who made this possible, in addition to publishing this study and in collaboration with the FDA and EMA, we are preparing to initiate a large cardiovascular outcomes study in early 2024.”
About the Health Outcomes Analysis The Health Outcomes Analysis is a non-interventional study derived from real-world data analysis that examines the cardiovascular safety of CONTRAVE®/MYSIMBA® (“Product”) versus a comparator product (locaserin). The primary objective of this study was to compare the incidence of major adverse cardiovascular events [MACE] between patients who received CONTRAVE®/MYSIMBA® and patients who received the comparator therapy. The primary analyzes included 12,475 patients starting CONTRAVE®/MYSIMBA® and 12,171 patients starting comparator therapy, with a median follow-up of over 1,700 days. Overall, the incidence rate of MACE per 1,000 person-years was lower in the CONTRAVE®/MYSIMBA® group than in the comparison group. The results showed that there was no statistically significant difference in the incidence rates of non-fatal acute myocardial infarction (AMI) and stroke between the CONTRAVE®/MYSIMBA® group and the comparison group.
About CONTRAVE/MYSIMBA CONTRAVE®, also marketed in the European Union and European Economic Area under the name MYSIMBA®, is an extended-release, fixed-dose combination of naltrexone and bupropion (Naltrexone HCL/Bupropion HCL) intended as a supplement to a calorie-restricted diet and increased physical activity for chronic weight control is indicated in adults with an initial body mass index (BMI) of 30 kg/m2 or more (obese), or in adults with a BMI of 27 kg/m2 or more (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol or type 2 diabetes.
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