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Source: cision | Published on: Wednesday, 18 October 2023
BRENTWOOD, Tenn., Oct. 18, 2023 -- Currax Pharmaceuticals LLC ("Currax") today announced top-line results from a Cardiovascular Health Outcomes Analysis (HOA). This study evaluated the cardiovascular safety of CONTRAVE®/MYSIMBA®, a weight management drug. The real-world study compared CONTRAVE®/MYSIMBA® to a similar product for the purpose of measuring major adverse cardiovascular events (MACE). The primary analysis included over 24,600 patients with an average follow-up of over 1700 days.
Researchers found no evidence of excess cardiovascular risk and no statistically significant difference in MACE between the CONTRAVE®/MYSIMBA® group and the comparator group. The HOA results are consistent with the four previous randomized clinical trials and more than nine years of post-marketing safety surveillance data in over 600,000 patient years of product usage. These results substantiate further understanding of the cardiovascular safety profile of CONTRAVE®/MYSIMBA®.
"We are pleased to see the results from this cardiovascular health outcomes analysis which included long-term follow-up of patients prescribed CONTRAVE®/MYSIMBA®," said Michael Kyle M.D., Currax SVP, Chief Medical Officer. "We plan to share the full study report with both the Food and Drug Administration and the European Medicines Agency in the coming days; and the full HOA study results will be published in a scientific publication in the near future."
"We commenced this important safety study almost two years ago with the support from leading experts in the field of real-world evidence analysis. I am pleased with the result and what it means for patients taking CONTRAVE®/MYSIMBA®," said Currax President and CEO, George Hampton. "I am grateful to all who made this possible. In addition to the publication of this study, and in collaboration with the FDA and EMA, we are preparing to initiate a large cardiovascular outcomes trial in the beginning of 2024."
About the Health Outcomes Analysis
The Health Outcomes Analysis is a real-world evidence, non-interventional study which evaluated the cardiovascular safety of CONTRAVE®/MYSIMBA® ("Product") to a comparator product (Locaserin). The primary objective of this study was to compare the incidence of major adverse cardiovascular events [MACE] between initiators of CONTRAVE®/MYSIMBA® and initiators of the comparator. The primary analyses included 12,475 patients who initiated CONTRAVE®/MYSIMBA® and 12,171 patients who initiated the comparator with a mean follow-up of over 1,700 days. Overall, the incidence rate of MACE per 1,000 person-years in the CONTRAVE®/MYSIMBA® group was lower than in the comparator group. The results indicated there was no statistically significant difference in incidence rates of non-fatal acute myocardial infarction (AMI) and stroke between the CONTRAVE®/MYSIMBA® group and the comparator group.
About CONTRAVE/MYSIMBA
CONTRAVE®, also marketed as MYSIMBA® in the European Union and European Economic Area, is an extended release fixed dose combination of naltrexone and bupropion (naltrexone HCL/bupropion HCL) indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or adults with a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes.
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