Currax Pharmaceuticals: CONTRAVE®/MYSIMBA® demonstrates no increased risk in major adverse cardiac events in a large, long-term real-world evidence study
BRENTWOOD, Tenn., Oct. 18, 2023 /PRNewswire/ — Currax Pharmaceuticals LLC (“Currax”) today announced top-line results from a Cardiovascular Health Outcomes Analysis (HOA). This study evaluated the cardiovascular safety of CONTRAVE®/MYSIMBA®, a weight management drug. The real-world study compared CONTRAVE®/MYSIMBA® to a similar product for the purpose of measuring major adverse cardiovascular events (MACE). The primary analysis included over 24,600 patients with an average follow-up of over 1700 days.
Researchers found no evidence of excess cardiovascular risk and no statistically significant difference in MACE between the CONTRAVE®/MYSIMBA® group and the comparator group. The HOA results are consistent with the four previous randomized clinical trials and more than nine years of post-marketing safety surveillance data in over 600,000 patient years of product usage. These results substantiate further understanding of the cardiovascular safety profile of CONTRAVE®/MYSIMBA®.
“We are pleased to see the results from this cardiovascular health outcomes analysis which included long-term follow-up of patients prescribed CONTRAVE®/MYSIMBA®,” said Michael Kyle M.D., Currax SVP, Chief Medical Officer. “We plan to share the full study report with both the Food and Drug Administration and the European Medicines Agency in the coming days; and the full HOA study results will be published in a scientific publication in the near future.”
“We commenced this important safety study almost two years ago with the support from leading experts in the field of real-world evidence analysis. I am pleased with the result and what it means for patients taking CONTRAVE®/MYSIMBA®,” said Currax President and CEO, George Hampton. “I am grateful to all who made this possible. In addition to the publication of this study, and in collaboration with the FDA and EMA, we are preparing to initiate a large cardiovascular outcomes trial in the beginning of 2024.”
About the Health Outcomes Analysis
The Health Outcomes Analysis is a real-world evidence, non-interventional study which evaluated the cardiovascular safety of CONTRAVE®/MYSIMBA® (“Product”) to a comparator product (Locaserin). The primary objective of this study was to compare the incidence of major adverse cardiovascular events [MACE] between initiators of CONTRAVE®/MYSIMBA® and initiators of the comparator. The primary analyses included 12,475 patients who initiated CONTRAVE®/MYSIMBA® and 12,171 patients who initiated the comparator with a mean follow-up of over 1,700 days. Overall, the incidence rate of MACE per 1,000 person-years in the CONTRAVE®/MYSIMBA® group was lower than in the comparator group. The results indicated there was no statistically significant difference in incidence rates of non-fatal acute myocardial infarction (AMI) and stroke between the CONTRAVE®/MYSIMBA® group and the comparator group.
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.
CONTRAVE Important Safety Information and Indication
WHAT IS CONTRAVE?
CONTRAVE is a prescription weight-loss medicine that may help some adults with a 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, lose weight and keep the weight off.
CONTRAVE should be used with a reduced-calorie diet and increased physical activity.
It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to heart problems or stroke.
It is not known if CONTRAVE is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products.
CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation).
IMPORTANT SAFETY INFORMATION
CONTRAVE can cause serious side effects including:
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.
CONTRAVE is not approved for use in children under the age of 18.
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.
Tell your healthcare provider about all of your medical conditions including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant or planning to become pregnant; or breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
CONTRAVE may cause serious side effects, including:
- Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who take higher doses of CONTRAVE, have certain medical conditions, or take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away.
- Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death.
Get emergency medical help right away if you take opioids and you:
- have trouble breathing
- become very drowsy with slowed breathing
- have slow, shallow breathing
- feel faint, very dizzy, confused, or have unusual symptoms
- Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery.
- Severe allergic reactions. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing.
- Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE.
- Liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness. Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem.
- Manic episodes. Bupropion can cause some people who were manic or depressed in the past to become manic or depressed again.
- Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your healthcare provider to find out if you are at risk for angle‐closure glaucoma and to get treatment to prevent it if you are at risk.
- Increased risk of low blood sugar in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE.
The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. These are not all of the possible side effects of CONTRAVE.
About Currax Pharmaceuticals LLC
Currax Pharmaceuticals LLC is a specialty pharmaceutical business focused on acquiring and commercializing prescription medicines worldwide. 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®. For more information, please visit www.curraxpharma.com.