Bupropion Hydrobromide

Company Introduces Multimedia Resources to Bring Awareness of SAD LAVAL, QC / ACCESSWIRE / November 8, 2023 / As daylight saving time concluded for much of the US on November 5, and as the seasons change and the days grow shorter, many people may find themselves grappling with the onset symptoms of seasonal affective disorder (SAD). SAD is a type of depression that follows a seasonal pattern and most often occurs with the change to the fall-winter season. Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC), a global diversified pharmaceutical company dedicated to advancing global health, is helping to raise awareness about the importance of SAD symptom recognition and dialogue with a healthcare professional. Specifically, Bausch Health has introduced several comprehensive initiatives to raise awareness for SAD symptoms and prevention, including a national television ad for its antidepressant APLENZIN® (bupropion hydrobromide) extended-release tablets, the only FDA-approved bupropion hydrobromide that is indicated for the prevention of SAD. The campaign is designed to inform individuals about SAD symptoms during the autumn and winter months and to encourage people diagnosed with SAD to engage in a dialogue with a healthcare professional about potential prevention and treatment-related strategies as needed. "SAD is a seasonal type of depression that manifests itself in the fall and winter months. When there's less sunlight outside, a person's natural ability to regulate certain chemicals can be disrupted which may impact depression," said Eric Guenin, PharmD, Ph.D., MPH, executive director, medical affairs, Bausch Health. "Prevention is key, when possible, so people must be aware of some of the symptoms of SAD, such as feeling depressed most of the day almost every day, losing interest in activities they once enjoyed, experiencing low energy, facing difficulty sleeping, weight changes, and be encouraged to discuss them with a healthcare professional as preventive treatment options exist." In addition to the ad campaign, there is a revamped APLENZIN website, which features a SAD fact sheet as well as a new patient engagement program called "Real Talk with APLENZIN" that provides subscribers with helpful tools and support. The site also includes a downloadable health questionnaire and "mood tracker" that provides patients practical tools to share and discuss with a healthcare professional, who can determine if there is a seasonal pattern to their symptoms. To learn more about APLENZIN please see Important Safety Information including boxed warning below and visit . About SAD SAD is a type of depression that follows a seasonal pattern. Symptoms often occur during the fall and winter months. SAD is more than the "winter blues," it is a serious mental health condition. When there's less sunlight outside, a person's natural ability to regulate certain chemicals can be disrupted which may impact depression. And that may lead to symptoms of SAD. The seasonal symptoms of SAD can include but are not limited to feeling depressed most of the day, nearly every day; losing interest in activities you once enjoyed; feeling hopeless or worthless; withdrawing socially; overeating, particularly craving carbohydrates; weight gain; and oversleeping. About APLENZIN APLENZIN (bupropion hydrobromide) is an antidepressant indicated for the treatment of major depressive disorder and prevention of SAD. APLENZIN is the only FDA-approved bupropion hydrobromide and offers extensive clinical experience in patients with MDD or SAD. APLENZIN is a once-daily, single tablet available in 3 dosage strengths, with no generic substitute. Recommended dosing for patients with SAD includes initiating treatment in the fall and discontinuing in early spring, as prescribed by a healthcare professional. For more information, visit . INDICATION APLENZIN® (bupropion hydrobromide extended-release tablets) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder). IMPORTANT SAFETY INFORMATION WARNING: CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS Suicidal Thoughts or Actions and Antidepressant Drugs Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. APLENZIN has not been evaluated for use in patients under the age of 18. Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Although APLENZIN is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking. Some people have had serious side effects while taking bupropion to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems. Stop taking APLENZIN and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take APLENZIN. In many people, these symptoms went away after stopping APLENZIN, but in some people, symptoms continued after stopping APLENZIN. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking APLENZIN, tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion. What Other Important Information Should I Know About APLENZIN? Seizures: There is a chance of having a seizure (convulsion, fit) with APLENZIN, especially in people with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking APLENZIN unless your healthcare provider has said it is okay to take them. If you have a seizure while taking APLENZIN, stop taking the tablets and call your healthcare provider right away. High blood pressure (hypertension): Some people get high blood pressure that can be severe while taking APLENZIN. Manic episodes: Some people may have periods of mania while taking APLENZIN. If you have any of the following symptoms of mania, call your healthcare provider: greatly increased energy severe trouble sleeping racing thoughts reckless behavior unusually grand ideas excessive happiness or irritability talking more or faster than usual Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking APLENZIN, including delusions (e.g., believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider. Visual problems: Some people are at risk of glaucoma which can present as: eye pain, changes in vision, or swelling and redness around the eye if they take APLENZIN. You should see an eye doctor to determine whether you are at risk prior to starting therapy. Severe allergic reactions: Some patients have severe allergic reactions to APLENZIN. Stop taking APLENZIN and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction. Do not take APLENZIN if you: have or had a seizure disorder or epilepsy have or had an eating disorder such as anorexia nervosa or bulimia are taking any other medicines that contain bupropion, including WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, ZYBAN, or FORFIVO XL. Bupropion is the same active ingredient that is in APLENZIN drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid do not take an MAOI within 2 weeks of stopping APLENZIN unless directed to do so by your healthcare provider do not start APLENZIN if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider are allergic to the active ingredient in APLENZIN, bupropion, or to any of the inactive ingredients Although APLENZIN is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) as ZYBAN, which is used to help patients quit smoking. Before taking APLENZIN, tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems or any symptoms you had during other times you tried to quit smoking with or without bupropion. Also, tell your healthcare provider about your other medical conditions, including if you: have liver problems, especially cirrhosis of the liver have kidney problems have, or have had, an eating disorder such as anorexia nervosa or bulimia have had a head injury have had a seizure (convulsion, fit) have a tumor in your nervous system (brain or spine) have had a heart attack, heart problems, or high blood pressure are a diabetic taking insulin or other medicines to control your blood sugar drink alcohol abuse prescription medicines or street drugs are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take APLENZIN during pregnancy, and about registering with the National Pregnancy Registry by calling 1-844-405-6185 are breastfeeding. APLENZIN passes into your milk in small amounts Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or cause other serious side effects if you take them while you are using APLENZIN. The most common side effects of APLENZIN include: trouble sleeping, stuffy nose, dry mouth, dizziness, feeling anxious, nausea, constipation, and joint aches. Click here to read the Medication Guide carefully before you start using APLENZIN. If you have any questions about APLENZIN, ask your healthcare provider or pharmacist. Click here for full Prescribing Information, including Medication Guide and Boxed Warning regarding suicidal thoughts and actions. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also contact Bausch Health Customer Service at 1-800-321-4576. About Bausch Health Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (908) 541-3785 Investor Contact: ir@bauschhealth.com (908) 541-2102 (877) 281-6642 (toll free) References Hansen BT, et al. Daylight Savings Time Transitions and the Incidence Rate of Unipolar Depressive Episodes. Epidemiology. 2017;28(3):346-353. American Psychiatric Association. Seasonal affective disorder (SAD). . Accessed September 1, 2022. Meesters Y, Gordijn MCM. Seasonal affective disorder, winter type: current insights and treatment options. Psychol Res Behav Manag. 2016;9:317-327. National Institute of Mental Health. Seasonal affective disorder. . Accessed September 1, 2022. APLENZIN (bupropion hydrobromide extended-release) Prescribing Information. Bausch Health Companies Inc. Melrose S. Seasonal affective disorder: an overview of assessment and treatment approaches. Depress Res Treat. 2015;2015:178564. APLENZIN is a trademark of Bausch Health Companies Inc. or its affiliates. Any other product/brand names and/or logos are trademarks of the respective owners. © 2023 Bausch Health Companies Inc. or its affiliates. APL.0132.USA.23 SOURCE: Bausch Health Companies Inc. View source version on accesswire.com:

A screenshot from Bausch's “Looking Forward” campaign With the nights drawing in, Bausch Health is taking the plunge on the first-ever TV spot for its seasonal affective disorder (SAD) drug Aplenzin. The ad is designed to encourage people who withdraw, oversleep and overeat as fall turns to winter to talk to their doctors about ways to manage their symptoms.  Valeant Pharmaceuticals, which now goes by Bausch, won (PDF) FDA approval for Aplenzin in SAD 11 years ago but never committed to a TV campaign in the indication. Now, one year after the Centers for Medicare and Medicaid Services clarified the coding for the indication, Bausch has launched “Looking Forward,” a campaign it is calling the first-ever TV commercial for a drug to prevent autumn-winter SAD. The ad opens with plaintive piano playing over footage of a woman flicking through a calendar of photos of herself. Starting in May, the photos show the woman looking happy throughout the summer months, gardening and toasting marshmallows on a fire. But the tone changes in the fall months, when we see the woman looking anxious and staring out of a window. Over the footage, the voiceover explains that they noticed their mood changing with the seasons. “I felt depressed, avoided my family and friends, gained weight and slept too much during the colder months,” the woman says.  A conversation with a healthcare professional led to a diagnosis of SAD, which the woman calls a serious medical condition and a type of depression that can occur in the fall and winter. “When treated with medication, SAD is preventable,” the woman says. “To help manage my seasonal depression, my healthcare professional prescribed Aplenzin.” The Aplenzin line is the cue for a shift in tone. The music lifts and the woman, who was previously sitting on a sofa looking depressed, is seen happily cooking, getting dressed and leaving the house. The ad ends with a call for people to talk to healthcare professionals to “stay ahead of depression,” with the first letter of each word highlighted to spell SAD.  Bausch, which will run the ad on connected TV throughout the winter, is supporting the commercial with new content on the Aplenzin website. The site now hosts “Real Talk,” an engagement campaign intended to help patients by providing resources such as a tool for starting conversations with doctors. Bausch is pushing Aplenzin ahead of the anticipated loss of exclusivity on the drug in 2026.