BRENTWOOD, Tenn., Aug. 27,
2024 /PRNewswire/ -- Currax Pharmaceuticals LLC
("Currax") today announced the results of a Cardiovascular Health
Outcomes Analysis (HOA). The results showed there is no evidence of
excess cardiovascular risk and no statistically significant
difference in major adverse cardiovascular events (MACE)
between CONTRAVE®/MYSIMBA® and the
comparator group.1 The study, presented by Dr.
Dustin Burns at the International
Society for Pharmacoepidemiology (ISPE) conference, held
August 24-28th in
Berlin, Germany, included more
than 24,600 people with an average follow-up of four and a half
years.
"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.
About the INFORMUS Trial
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
hmueller@curraxpharma.com
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.
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