Currax Pharmaceuticals Announces First Patient Screened into the INFORMUS Cardiovascular Outcomes Trial
Press Release

Currax Pharmaceuticals Announces First Patient Screened into the INFORMUS Cardiovascular Outcomes Trial

BRENTWOOD, TENNESSEE, UNITED STATES, January 25, 2024 /EINPresswire.com/ — Currax Pharmaceuticals LLC (“Currax”) announces the first patient screened and accepted into the CONTRAVE® INFORMUS Cardiovascular Outcomes Trial (NB-CVOT3). The initiation of this study follows the October 2023 announcement of the favorable top-line results of the completed Cardiovascular Health Outcomes Analysis (HOA) where no evidence was found of excess cardiovascular risk and there was no statistically significant difference of major adverse cardiovascular events (MACE) between CONTRAVE and the active comparator group.

“We are thrilled to be commencing the INFORMUS trial for CONTRAVE,” said Michael Kyle, M.D., Currax SVP, Chief Medical Officer. “Over the past several years, we worked diligently with regulatory agencies to develop this study protocol. To reach agreement with the FDA and initiate patients into the trial is a significant milestone for this product, these patients, and this program.”

The HOA results substantiated the cardiovascular safety profile of CONTRAVE, and the initiation of the INFORMUS trial addresses regulatory post-marketing commitments. INFORMUS will further characterize long-term cardiovascular safety for patients taking CONTRAVE. The HOA study is completed and is expected to be published later this year.

“Our clinical team successfully achieved an on-time launch of the INFORMUS trial through strong collaboration and support from the FDA,” said Currax President and CEO George Hampton. “This is an important trial for patients, as CONTRAVE is now the number one prescribed branded oral medication for the treatment of obesity.”

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 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.

Media Contact
Hope Mueller
SVP, Strategy and Corporate Development
[email protected]

Hope Mueller
Currax Pharmaceuticals
[email protected]

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 www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Full Prescribing Information, including Medication Guide, for CONTRAVE.
More information is available on www.ContraveHCP.com  and www.Contrave.com.

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), a