Bupropion Hydrochloride/Naltrexone Hydrochloride

At its latest meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use backed five new medicines. After failing to pass muster with England’s drug reimbursement watchdog earlier this month, Eli Lilly’s Alzheimer’s disease med Kisunla (donanemab) also got a rejection from EU regulators.European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against a marketing authorization for the drug’s use in early symptomatic Alzheimer’s disease. The agency argued that the benefits of the treatment “were not large enough” to outweigh the risk of potentially fatal events such as swelling and bleeding of the and brain, a side effect known as amyloid-related imaging abnormalities (ARIA).Lilly will seek a re-examination of the decision. The company hopes to “continue our discussions with the agency to bring donanemab to the millions of people across Europe suffering from this relentless, fatal disease,” EVP and president of Lilly International Ilya Yuffa said in a company statement Friday. The drugmaker “remains confident in the safety and effectiveness of donanemab,”   As Eisai and Biogen can attest, European regulators are cautious about the safety concerns of Alzheimer’s drugs. The partners’ Kisunla-rivaling Leqembi eventually won CHMP’s favor in February, albeit in a restricted patient population of those with mild Alzheimer’s-related cognitive impairment or dementia who carry one or no copies of the ApoE4 gene.The positive opinion there came after the regulator first denied the treatment, citing benefits that “do not counteract the risk of serious adverse events” such as ARIA. The ARIA safety risk is greater in those who have two copies of the ApoE4 gene. Over in England, NICE recently declined to recommend both of the Alzheimer’s drugs for coverage in the region’s National Health Service for the second time, despite both winning approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). The agency cited a review from an independent committee on additional clinical data that ultimately confirmed that the medicines “are not currently cost effective.”In the U.S., both Kisunla and Leqembi are FDA-approved with a black boxed warning label for ARIA risk. Meanwhile with CHMP, several other drugmakers such as Bristol Myers Squibb received good news. The committee issued a positive opinion on the company’s subcutaneous formulation of blockbuster oncology drug Opdivo, clearing the way for an EU approval. Seven drugs—including AstraZeneca’s Calequence, Johnson & Johnson’s Tremfya and Seqirus’ flu vaccine Flucelvax—won label extensions, while Incyte’s Pemazyre was not recommended for one.The committee also wrapped up its review of Orexigen Therapeutics’ Currax-partnered weight loss med Mysimba, which was being evaluated again due to concerns of potential long-term cardiovascular risks. While CHMP determined that the benefits of the drug outweigh the risks, the company must provide more information on long-term use through an ongoing study that should wrap up in 2028. Since the available data only shows that there are no safety concerns when Mysimba is used for up to 12 months, the committee warned that treatment should be stopped after one year if weight loss of at least 5% of initial body weight isn’t maintained, and that doctors should closely monitor a patient’s yearly progress on the med. The drug was first approved in Europe in 2015. 

BRENTWOOD, Tenn., March 11, 2025 /PRNewswire/ -- Currax Pharmaceuticals LLC ("Currax"), a specialty pharmaceutical company and manufacturer of the #1 branded oral weight loss medication CONTRAVE® (naltrexone HCl/bupropion HCl), today announced the publication of its Cardiovascular Health Outcomes Analysis (HOA) for CONTRAVE®/MYSIMBA® in Obesity Pillars, the official journal of the Obesity Medicine Association. This peer-reviewed study, based on electronic health record data from more than 24,600 patients followed for over 4.7 years, found no evidence of excess cardiovascular risk and no statistically significant difference in major adverse cardiovascular events (MACE) between CONTRAVE/MYSIMBA and the comparator drug. The study's publication provides important real-world evidence that further substantiates the cardiovascular safety profile of CONTRAVE/MYSIMBA building on findings from prior clinical trials, a systemic literature review, two published FDA Adverse Event Reporting System (FAERS) database studies, and over ten years of post-marketing safety surveillance. These results provide valuable insights to support regulatory and clinical decision-making in the treatment of obesity. "The publication of this analysis in Obesity Pillars underscores the utility of evaluating long-term cardiovascular outcomes in routine clinical practice," said Michael Kyle, M.D., SVP, Chief Medical Officer of Currax Pharmaceuticals. "The findings further substantiate the cardiovascular safety profile of CONTRAVE/MYSIMBA, aligning with previous clinical and observational studies." CONTRAVE, approved in the U.S. and marketed in Europe as MYSIMBA, has been studied extensively in both randomized clinical trials and observational settings. The latest analysis builds upon prior research, including the LIGHT trial, and complements the ongoing INFORMUS trial, a large-scale cardiovascular outcomes study, which now has enrolled more than 3,000 patients and is designed to meet regulatory post-marketing requirements to further characterize long-term cardiovascular safety. "Obesity is a serious chronic disease, and it's critical that healthcare professionals have access to rigorous, data-driven evidence when considering treatment options," said George Hampton, President and CEO of Currax Pharmaceuticals. "Currax continues to invest in clinical trials designed to increase the utility of Contrave for physicians treating obesity." The full study is available in Obesity Pillars: About Currax Pharmaceuticals LLC Currax Pharmaceuticals LLC is a specialty pharmaceutical business focused on tackling 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®. For more information, please visit . WHAT IS CONTRAVE? 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. 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see the Full Prescribing Information, including Medication Guide, for CONTRAVE. Media Contact [email protected] SOURCE Currax Pharmaceuticals LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED