 |
"The study's results found no evidence of increase in cardiovascular risk among initiators of CONTRAVE, which is informative for healthcare providers and patients considering this treatment option for obesity," said Dustin Burns, Ph.D., GStat, the presenting author and Senior Managing Scientist at Exponent who led the analysis.
These results are consistent with the four previous randomized clinical trials, the previous LIGHT Trial, and more than ten years of post-marketing safety surveillance data with over 700,000 patient years of product usage. These study results help to substantiate the cardiovascular safety profile of CONTRAVE/MYSIMBA and the ongoing INFORMUS trial.
In addition, the ongoing INFORMUS trial will address the regulatory post-marketing commitments and further characterize the long-term cardiovascular safety for patients taking CONTRAVE/MYSIMBA. In January 2024, the first patient was enrolled in the INFORMUS trial, and to date there are over 1,800 patients randomized.
"We are honored to have Dr. Burns present these favorable findings at ISPE," Michael Kyle, M.D., SVP Chief Medical Officer of Currax Pharmaceuticals said. "Achieving this milestone and the affirmation of the cardiovascular safety of CONTRAVE is gratifying. Over the past four years, we worked exhaustively with regulatory agencies to fully characterize the cardiovascular safety of the product and these results are another proof-point of the positive benefit-risk of CONTRAVE/MYSIMBA."
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.
The INFORMUS Trial (NB-CVOT3) is a Phase IV, multi-center, prospective, randomized, pragmatic, double-blinded, placebo-controlled study intended to capture cardiovascular (CV) outcomes during real-world use of naltrexone/bupropion (CONTRAVE). Randomization will occur 1:1 between CONTRAVE and placebo. The primary endpoint includes comparison of major adverse cardiovascular events (MACE) between study subjects receiving CONTRAVE and subjects receiving placebo.
About Currax Pharmaceuticals LLC
Currax Pharmaceuticals LLC is a specialty pharmaceutical business focused on addressing the #1 and #2 causes of preventable death in the United States, smoking and obesity. Currax distributes a range of both branded and generic pharmaceutical products, including CONTRAVE® (naltrexone HCl/bupropion HCl), ONZETRA® Xsail® (sumatriptan nasal powder), Silenor® (doxepin), Treximet®, (sumatriptan/naproxen sodium), and the authorized generic of Treximet®.
Media Contact
Hope Mueller
SVP, Strategy and Corporate Development
1 D. Burns, et al. Evaluating the Cardiovascular Safety of Naltrexone/Bupropion in the United States. Abstract submitted for presentation at the 2024 International Society for Pharmacoepidemiology (ISPE) conference.