"Currax Pharmaceuticals LLC, a patient-first pharma company focused on tackling the number one and number two causes of preventable death in the United States, smoking and obesity, and manufacturer of branded oral weight loss medication Contrave (naltrexone HCl/bupropion HCl) announced that the US FDA has approved a second manufacturing site for Contrave, also marketed as Mysimba in the European Union and European Economic Area. This approval comes at a critical time as demand for effective obesity treatments surges worldwide and reinforces the company’s commitment to continuous patient access to treatment.
“At Currax Pharmaceuticals, we are steadfast in our commitment to ensuring that patients and healthcare providers have uninterrupted access to Contrave,” states Aaron Chesnut, vice president, technical operations. “Securing a second US FDA-approved drug product manufacturing site enhances our ability to respond to shifting industry conditions and safeguards against external factors that could impact production and distribution.”
The approval of this second site enhances production capacity, confirming continued patient access to Contrave while reinforcing the company’s broader commitment to obesity research and treatment. Currax is investing in manufacturing and advancing clinical research, and is working to provide reliable, evidence-based treatment options for patients and healthcare providers.
“As the obesity epidemic continues to rise, so does the need for dependable access to effective and affordable treatment options,” said George Hampton, president and CEO of Currax Pharmaceuticals. “As the only medication in the Reward System Modulator (RSR) class, Contrave is an important treatment option for physicians, particularly as the development programs continue to focus on the (GLP-1s).”
Along with diet and exercise, Contrave is a prescription weight-loss medicine that may help some adults with a BMI > 30 kg/m2 (obese) or with a BMI of > 27 kg/m2 (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off.
Suicidal thoughts or actions: One of the ingredients in Contrave is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.
While taking Contrave, you or your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking Contrave or when your dose changes.
Stop taking Contrave and call a healthcare provider right away if you or your family members notice any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood; trouble sleeping.
Do not take Contrave if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as Wellbutrin, Wellbutrin SR, Wellbutrin XL, Aplenzin and Zyban; have or have had an eating disorder called anorexia or bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and stop using them all of a sudden; are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs) in the past 14 days; or are allergic to any of the ingredients in Contrave.