2023-10-18 20:45:57
Brentwood-based pharmaceutical company, Currax Pharmaceuticals LLC, has announced the initial results from a Cardiovascular Health Outcomes Analysis (HOA) study. The study aimed to evaluate the cardiovascular safety of CONTRAVE®/MYSIMBA®, a weight management medication. The real-world study compared CONTRAVE®/MYSIMBA® with a similar product to measure major adverse cardiovascular events (MACE) and included over 24,600 patients with an average follow-up of over 1,700 days.
The results of the study revealed 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. These findings align with previous randomized clinical trials and over nine years of post-marketing safety monitoring data, which covered the use of the product by over 600,000 patients.
Dr. Michael Kyle, Currax SVP and Chief Medical Officer, expressed satisfaction with the results of the cardiovascular health outcomes analysis, emphasizing the long-term follow-up of patients on CONTRAVE®/MYSIMBA®. 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, with the complete results of the HOA study set to be published in a scientific publication.
George Hampton, President and CEO of Currax, acknowledged the support of leading experts in real-world evidence analysis in carrying out this important safety study. He expressed gratitude for everyone involved and highlighted its significance for patients taking CONTRAVE®/MYSIMBA®. In addition to publishing the study, Currax is preparing to initiate a large cardiovascular outcomes study in early 2024, in collaboration with the FDA and EMA.
The Health Outcomes Analysis was a non-interventional study based on real-world data analysis, comparing the cardiovascular safety of CONTRAVE®/MYSIMBA® with a comparator product (locaserin). The primary objective was to assess the incidence of major adverse cardiovascular events (MACE) between patients on CONTRAVE®/MYSIMBA® and those on the comparator therapy. The study included 12,475 patients starting CONTRAVE®/MYSIMBA® and 12,171 patients starting the 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 compared to the comparison group. The study results indicated no statistically significant difference in the incidence rates of non-fatal acute myocardial infarction (AMI) and stroke between the two groups.
CONTRAVE®/MYSIMBA® is an extended-release, fixed-dose combination of naltrexone and bupropion intended for use as a supplement to a calorie-restricted diet and increased physical activity for chronic weight control. It is indicated for adults with an initial body mass index (BMI) of 30 kg/m2 or more (obese) or 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.
For further information, please visit the Currax Pharmaceuticals website.
Press contact:
Hope Mueller,
SVP,
Strategy and Corporate Development,
hmueller@curraxpharma.com]
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