BRENTWOOD, TN, USA, July 23, 2024 / Biotech Newswire / -- Currax Pharmaceuticals LLC (“Currax”) today announced the approval of additional manufacturing site for CONTRAVE®/MYSIMBA® in the European Union (EU) and European Union Economic Areas (EEA).
The new site doubles the current production capacity of CONTRAVE/MYSIMBA and ensures continuity of supply, and the site has capacity to increase production when needed. An application to the U.S. Food & Drug Administration (FDA) for approval of this additional site is scheduled for Q3 2024. As supply constraints continue for GLP-1 anti-obesity medications, it is critical that patients have reliable supply and access to other non-GLP-1 treatment options.
CONTRAVE is the only anti-obesity medication in its class, the Reward System Modulator class (RMS), that is specifically designed to both reduce hunger and control cravings. Available in both the U.S. and Europe for more than 10 years, CONTRAVE has shown to be both safe and effective for the treatment of obesity with a collective use of greater than 650,000 patient years. CONTRAVE is an important and unique treatment option for physicians and patients because not only it is effective, but it is also affordable, with a price that is 40 to 60% less than the leading branded medications. The most common GI-related side effects were generally mild and transient in nature and subsided in the first 2-4 weeks.
“According to the World Health Organization (WHO), one in eight people are living with obesity and we believe those patients deserve consistent access to medications to treat their disease,” said George Hampton, President and CEO of Currax Pharmaceuticals. “Access to medications is one of our core values and reliability of supply is a critical component to access. We continue to invest heavily in our ability to supply the unprecedented increase in worldwide demand. This is especially important at a time when the GLP-1 companies are plagued with chronic supply issues,” he continued.
As treatment rates expand, it is critical that medication is available for both commercial and clinical programs. The primary clinical program for CONTRAVE is the INFORMUS trial. It is designed to further characterize the long-term cardiovascular safety of CONTRAVE, and within the first six months of the trial there have been more than 1300 patients enrolled and randomized.
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®.
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 NB-CVOT3 Protocol
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.
Contact
Currax Pharmaceuticals LLC
Hope Mueller
SVP, Strategy and Corporate Development
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Keywords: bupropion hydrochloride, naltrexone hydrochoride drug combination; Naltrexone; Bupropion; Pharmaceutical Preparations; European Union; Hunger; Craving; Anti-Obesity Agents; New Facility; Continuity of Supply; Anti-Obesity Treatment; CONTRAVE®/MYSIMBA®; GLP-1 Supply Issues; Currax Pharmaceuticals; manufacturing site approval; European Union (EU); European Union Economic Areas (EEA); production capacity; non-GLP-1 treatment options; Reward System Modulator class (RMS); hunger reduction; craving control; obesity treatment; George Hampton, CEO of Currax Pharmaceuticals; global demand; commercial programs; clinical programs; INFORMUS trial; cardiovascular safety; naltrexone and bupropion combination; chronic weight management
Source: Biotech Newswire