Diverticular Diseases

LAVAL, QC / ACCESSWIRE / March 6, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, Ltd., today announced that it is supporting a Phase 2 investigator-initiated study (IIS) of RELISTOR® (methylnaltrexone bromide: MNTX) in patients with resectable head and neck squamous cell carcinoma. An IIS is a study that is proposed, developed, and conducted by a qualified sponsor external to Bausch Health/Salix who assumes full responsibility for the study. The clinical study is being led by Juan P. Cata, M.D. at The University of Texas MD Anderson Cancer Center. The trial is designed to evaluate the potential of treating oral cavity squamous cell carcinoma patients with MNTX. It is a prospective, nonrandomized pilot "proof of concept" study where patients receive subcutaneous MNTX two weeks preoperatively and two weeks postoperatively. "The preclinical data and clinical suggestions point to potential activity against cancer," Robert Israel, M.D., Senior Vice President, Clinical and Medical Affairs, said. "Having Dr. Cata study this drug in head and neck cancer will shed light on how and if this agent could be further developed as a potential treatment option in neoplastic disease." Upon completion of the study, participants will be monitored every 3 months during the first two years. The primary endpoint is the successful administration of MNTX for two weeks preoperatively and postoperatively without interruption due to adverse events. Secondary endpoints include tumor viability, proliferation and apoptosis index, objective response rate, survival rates, and patient-reported outcomes. Identifier: NCT06162377. About RELISTOR RELISTOR® (methylnaltrexone bromide) is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. IMPORTANT SAFETY INFORMATION RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation. Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit pro using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their health care provider. Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal. Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal. The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment. A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child- Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated. In the clinical studies, the most common adverse reactions were: OIC in adult patients with chronic non-cancer pain RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%). RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%). OIC in adult patients with advanced illness RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%). To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800- FDA-1088 or Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection. About Salix Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit and connect with us on Twitter and LinkedIn. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. 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. Forward-looking Statements This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Bausch Health most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration, and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. ### Investor Contact: Media Contacts: ir@bauschhealth.com Kevin Wiggins (877) 281-6642 (toll-free) corporate.communications@bauschhealth.com (908) 541-3785 SOURCE: Salix Pharmaceuticals View the original press release on accesswire.com

A total of 29 abstracts, including three late-breaking presentations, demonstrate AbbVie and Allergan Aesthetics' shared commitment to advancing science across a spectrum of immune-mediated dermatologic conditions and aesthetic indications NORTH CHICAGO, Ill., March 6, 2024 /PRNewswire/ --AbbVie (NYSE: ABBV) and Allergan Aesthetics, an AbbVie company, today announced they will present 29 abstracts, including three late-breaking presentations, during the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12, in San Diego, California. The presented data across AbbVie and Allergan Aesthetics' extensive portfolios reinforce the companies' ongoing commitment to developing transformative medical dermatology and aesthetic treatments to advance and redefine the standard of care for patients. The oral and poster presentations from AbbVie highlight efficacy, durability and safety data across the company's dermatology portfolio. Notable presentations include: Efficacy data of RINVOQ® (upadacitinib) on nighttime itch and sleep disturbance, and minimal disease activity in patients with moderate-to-severe atopic dermatitis Data evaluating the efficacy of SKYRIZI® (risankizumab-rzaa) on difficult to treat areas including for the treatment of scalp and nail psoriasis compared to apremilast in adults with moderate psoriasis, and safety and efficacy of SKYRIZI® (risankizumab-rzaa) in adults with moderate to severe plaque psoriasis with palmoplantar (nonpustular) involvement Data evaluating changes in tissue-resident memory T cell (Trm) populations after high-induction dosing of SKYRIZI® (risankizumab-rzaa) in patients with moderate-to-severe plaque psoriasis AbbVie is also presenting data across a number of underserved dermatologic diseases across new and existing molecules. Key research includes: Phase 2 efficacy and safety data for lutikizumab (ABT-981), which has a novel mechanism of action, in the treatment of moderate to severe hidradenitis suppurativa being presented for the first time at a medical meeting Efficacy and safety results of a Phase 2, 52-week study for upadacitinib in the treatment of non-segmental vitiligo New data on disease and economic burden of alopecia areata in the United States "AbbVie's commitment to advancing standards of care in dermatology is underscored by the breadth of new research presented at AAD this year," said Andrew Anisfeld, Ph.D., vice president, global medical affairs, Immunology, AbbVie. "We are dedicated to improving patient outcomes and helping to redefine treatment expectations so that all patients may feel free in their own skin." With a growing pipeline of more than 60 programs in development, Allergan Aesthetics has one of the most robust portfolios for aesthetics innovation in the industry. At AAD the company will spotlight: Detailed results from two Phase 3 studies of onabotulinumtoxinA (BOTOX® Cosmetic) for the treatment of platysma prominence, an aesthetically unappealing disruption to the lines and contour of the lower face and neck that can occur as part of the natural aging process. Topline results shared in 2023 demonstrated all primary and secondary endpoints were met for both studies,1 and if approved, onabotulinumtoxinA will be the first and only neurotoxin for this indication. Data on the safety and effectiveness of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.2 JUVÉDERM® VOLUMA® XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to thirteen months with optimal treatment.2 Data on a novel cosmetic regimen for mild to moderate facial acne. "Allergan Aesthetics is focused on creating evidence-based products and technologies that advance aesthetics medicine and address the evolving needs of patients and providers globally," said John Maltman, Ph.D., vice president, global aesthetics medical affairs, Allergan Aesthetics. "With patient safety and optimal outcomes as our main priorities, we are proud to share our learnings and engage with the larger medical community at AAD." Select AbbVie and Allergan Aesthetics abstracts at AAD 2024 are outlined below. The 2024 AAD Annual Meeting e-Posters are available here and late-breaking sessions are available here. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally. About RINVOQ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.3 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Phase 3 trials of RINVOQ alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus (SLE), Takayasu arteritis, ulcerative colitis and vitiligo are ongoing.4-17 Use of upadacitinib in vitiligo is not approved and its safety and efficacy have not been evaluated by regulatory authorities. RINVOQ (upadacitinib) U.S. Uses and Important Safety Information3 RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended. RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. What is the most important information I should know about RINVOQ? RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots: Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor. Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away. Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting. Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results. Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. What should I tell my HCP BEFORE starting RINVOQ? Tell your HCP if you: Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as: Fever, sweating, or chills Shortness of breath Warm, red, or painful skin or sores on your body Muscle aches Feeling tired Blood in phlegm Diarrhea or stomach pain Cough Weight loss Burning when urinating or urinating more often than normal Have TB or have been in close contact with someone with TB. Are a current or past smoker. Have had a heart attack, other heart problems, or stroke. Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines. Have other medical conditions including liver problems, low red or white blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP. Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. Are pregnant or plan to become pregnant. Based on findings in animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose. There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110. Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects. Especially tell your HCP if you take: Medicines for fungal or bacterial infections Rifampicin or phenytoin Medicines that affect your immune system If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. What should I avoid while taking RINVOQ? Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects. What should I do or tell my HCP AFTER starting RINVOQ? Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weakness in one part or on one side of your body Slurred speech Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: Swelling Pain or tenderness in one or both legs Sudden unexplained chest or upper back pain Shortness of breath or difficulty breathing Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits. What are other possible side effects of RINVOQ? Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis). A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ. Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your healthcare provider. These are not all the possible side effects of RINVOQ. How should I take RINVOQ? RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. Please click here for the Full Prescribing Information and Medication Guide for RINVOQ. Globally, prescribing information varies; refer to the individual country product label for complete information. About SKYRIZI® (risankizumab-rzaa) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.18 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.18 Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.19 - 24 SKYRIZI® (risankizumab-rzaa) U.S. Indications and Important Safety Information25 SKYRIZI is a prescription medicine used to treat adults with: moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). active psoriatic arthritis (PsA). moderate to severe Crohn's disease. IMPORTANT SAFETY INFORMATION What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)? SKYRIZI is a prescription medicine that may cause serious side effects, including: Serious allergic reactions: Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness chest tightness skin rash, hives itching Infections: SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine. are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk. become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of SKYRIZI? SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?" Liver problems in Crohn's disease: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine. The most common side effects of SKYRIZI in people treated for Crohn's disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection. The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections. These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects. Use SKYRIZI exactly as your healthcare provider tells you to use it. SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. Please click here for Full Prescribing Information and Medication Guide for SKYRIZI. Globally, prescribing information varies; refer to the individual country product label for complete information. About Lutikizumab (ABT-981) Lutikizumab (ABT-981) is a dual-variable-domain interleukin (IL) 1α/1β antagonist being investigated in several immune-mediated diseases, including hidradenitis suppurativa (HS) and ulcerative colitis. Studies have shown IL 1α and 1β are elevated in HS lesions.26 Lutikizumab is an investigational agent and is not approved by regulatory authorities. Safety and efficacy have not been established. BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information BOTOX® Cosmetic (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet, and frown lines between the eyebrows in adults. Talk to your doctor about BOTOX® Cosmetic and whether it's right for you. There are risks with this product—the effects of BOTOX® Cosmetic may spread hours to weeks after injection causing serious symptoms. Alert your doctor right away as difficulty swallowing, speaking, breathing, eye problems or muscle weakness can be a sign of a life-threatening condition. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Patients with these conditions before injection are at the highest risk. Swallowing problems may last for several months. Side effects may include allergic reactions, neck and injection-site pain, fatigue and headache. Allergic reactions can include rash, welts, asthma symptoms, and dizziness. Don't receive BOTOX® Cosmetic if there's a skin infection. Tell your doctor your medical history, muscle or nerve conditions (including ALS/Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome), and medications, including botulinum toxins, as these may increase the risk of serious side effects. Please see BOTOX® Cosmetic Full Product Information including Boxed Warning and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. JUVÉDERM® VOLUMA® XC Important Information INDICATIONS JUVÉDERM® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face, for augmentation of the chin region to improve the chin profile, and for supraperiosteal injection to augment the temple region to improve temple hollowing in adults over the age of 21. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Not for patients with a history of anaphylaxis, presence of multiple severe allergies, or allergies to Gram-positive bacterial proteins or lidocaine in these products. WARNINGS: Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Rare but serious adverse events associated with the intravascular injection of dermal fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Treatment should be deferred where there is active infection or inflammatory process at the injection site. PRECAUTIONS: This product should only be used by healthcare professionals who are knowledgeable about the anatomy and the product for use in indicated areas, and who have appropriate training in facial anatomy, vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications. The safety for use during pregnancy, breastfeeding, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been established. Dermal filler implantation carries a risk of infection. Use in patients who are taking products that prolong bleeding may increase bruising/bleeding at the injection site. Use with caution in patients on immunosuppressive therapy. Patients may experience late-onset adverse events with injectable gel implants. ADVERSE EVENTS: The most common reported side effects were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. The majority were mild or moderate in severity. To report an adverse reaction, please call Allergan® Product Support at 1-877-345-5372. Please visit rxabbvie.com for more information. The products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner. SkinMedica® Most SkinMedica® products are intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References AbbVie. (2023, September 18). Allergan Aesthetics Announces Positive Topline Results from Second Phase 3 Study of OnabotulinumtoxinA (BOTOX® Cosmetic) for the Treatment of Platysma Prominence [Press release]. JUVÉDERM® VOLUMA® XC Patient Labeling for Temple. 2024. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2023. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. Available at: . Accessed March 24, 2023. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults with Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE). ClinicalTrials.gov. Available at: . Accessed March 24, 2023. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. Available at: . Accessed March 24, 2023. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. Available at: . Accessed March 24, 2023. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. Available at: . Accessed March 24, 2023. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. Available at: . Accessed February 22, 2024 A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2). ClinicalTrials.gov. Available at: . Accessed February 22, 2024 A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (AD Up). ClinicalTrials.gov. Available at: . Accessed February 22, 2024. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. Available at: . Accessed March 30, 2023. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: . Accessed March 30, 2023. Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: . Accessed February 19, 2024. A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: . Accessed February 19, 2024 A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: . Accessed February 19, 2024. A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: . Accessed February 19, 2024. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11. A Study on the long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis. ClinicalTrials.gov. 2021. Available at: . Accessed on February 17, 2023. A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2021. Available at: . Accessed on March 8, 2022. A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: . Accessed on March 8, 2022. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. Available at: . Accessed on March 8, 2022. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: . Accessed on March 8, 2022. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: . Accessed on March 8, 2022. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc. VanderZee et al British Journal of Dermatology (2011) 164, p1292–98; Kanni et al (2015) PLoS ONE 10(6): e0130522. Company Codes: NYSE:ABBV

ColoTest, a new over-the-counter FIT test that requires one stool sample and offers instant results with no lab testing, is now for sale through local pharmacies CLEVELAND, Feb. 27, 2024 /PRNewswire/ -- Reese Pharmaceutical is expanding its over-the-counter (OTC) diagnostic portfolio with the launch of ColoTest®, an at-home Fecal Immunochemical Test (FIT) that identifies the presence of hidden blood in the stool in support of the early detection of colon cancer or gastrointestinal disorders such as colitis, diverticulitis, and polyps. The FDA-cleared ColoTest is now available for sale through a growing number of pharmacies – just in time for Colorectal Cancer Awareness Month in March. A recent report by the American Cancer Society revealed a troubling spike in new colon and rectal cancer diagnoses across the US. Nearly double the number of young adults under 55 are being diagnosed with colorectal cancer compared to a decade ago, and colorectal cancer is now the leading cause of cancer deaths in men under the age of 50 (second in women under 50). "90% of colon cancer-related deaths are thought to be preventable if caught early, and yet more than 29 million Americans are not screening for it. With colon cancer rates on the rise, it is more important than ever for people to be proactive. We're proud to introduce ColoTest to help meet this challenge by delivering a convenient, affordable, non-invasive screening option that enables people to identify invisible blood in stool, a key warning sign for colorectal cancer, diverticulitis, gastrointestinal disorders, colitis and polyps. This test is performed in the comfort of your own home with results at home as soon as 1 minute," said Jeffrey Reese, President, of Reese Pharmaceutical. With a suggested retail price of $19.99, ColoTest 1ct is inexpensive and easy to use. You simply place a sheet of paper from the kit over the toilet to collect a sample, brush a portion into the tube, add the sampler, and wait for a reaction. Results appear in as little as one minute. Those with a positive test are advised to contact their doctor for additional testing, such as a colonoscopy. While colonoscopies remain the gold standard of screening for colorectal cancer, only some people become eligible for the procedure before age 45, with others feeling adverse to colonoscopy or lacking insurance coverage. ColoTest offers a highly accurate and discreet alternative that anyone can access regardless of age, which may help get more young adults screened sooner. Reese Pharmaceutical has been serving the pharmaceutical industry for over 100 years with a portfolio of products across cough and cold, digestive care, family planning, feminine health, and first aid. The company received U.S. Food and Drug Administration (FDA) clearance for ColoTest in September 2023. The new test will be on shelves in major retail stores later this spring. For more information on ColoTest, click here. About Reese Pharmaceutical Founded in 1907 and headquartered in Cleveland, Ohio, Reese Pharmaceutical Company is a privately held manufacturer of OTC branded and private label products selling to national and regional discount chains, food and grocery, drug wholesalers, co-ops, and independent pharmacies. Media Contact: Karen Laverty, karen@emediajunction.com