Gangrene

MALVERN, Pa., Dec. 2, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of its ADRENALIN® (epinephrine in 0.9% sodium chloride injection) ready-to-use premixed bag, the first and only FDA-approved, manufacturer-prepared epinephrine premixed intravenous (IV) bag. "The first-ever ready-to-use epinephrine premixed bag represents an advancement for both providers and patients thanks to a delivery system that provides greater workflow efficiency, saves time, and reduces the risk of medication error," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions & Generics. "We are proud to provide critical care products like ADRENALIN® bags—ready when and where our customers need them—through our TruDelivery® portfolio." The ADRENALIN® premixed bag is the latest addition to Endo Injectable Solutions' TruDelivery® product line and platform. Ready-to-use products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow, and reduce the chance for preparation error—all of which support quality patient care. The ADRENALIN® premixed bag does not require compounding, diluting, mixing, or transferring, which may reduce waste. The single-port IV tubing reduces risk of inadvertently adding other medications to bag. The product also has a 24-month shelf life at room temperature. Endo also offers ADRENALIN® (epinephrine injection, USP) in 1 mL single-dose vials and 30 mL multi-dose vials. ADRENALIN® is used in the treatment of hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When Adrenalin is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough. Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein. Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. ADVERSE REACTIONS: Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. DRUG INTERACTIONS: Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, and ergot alkaloids. Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, catechol-O-methyltransferase (COMT) inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides, and quinidine. Observe for development of cardiac arrhythmias. Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. USE IN SPECIFIC POPULATIONS: Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. INDICATION AND USAGE Hypotension associated with Septic Shock Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Click for Full Prescribing Information. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Mr. Sims and any statements relating to product launch, quality, efficacy, improved treatment, workflow efficiencies, reduced risks, waste or costs, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, regulatory compliance, unexpected litigation or disputes, Endo's ability to successfully implement and execute on its strategies and initiatives, and changes in competitive, market or regulatory conditions. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Human Research Ethics Committee approval received for registrational Phase 3 trial for RECCE® 327 topical gel in patients with diabetic foot infectionsRegistrational Phase 3 clinical trial for diabetic foot infections to be conducted across Indonesia, one of the world's largest diabetes patient populationsData read-out and regulatory submission expected in late 2025 with potential approval and commercial launch in H1 2026Bilateral initiative supported by Australian and Indonesian governments with clinical support from leading Indonesian biopharmaceutical company PT Etana Biotechnologies SYDNEY, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it received Human Research Ethics Committee approval to commence a registrational Phase 3 trial of RECCE® 327 as a topical gel (R327G) for the treatment of diabetic foot infections (DFI). Ethics approval signifies that Recce has met the safety and efficacy testing required to proceed with this large-scale, late-stage clinical trial. “Today marks the achievement of a landmark milestone in Recce’s clinical program development,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We are thankful for the unparalleled support from our Indonesian partners in bringing our innovative anti-infective therapy to patients in need. This welcomed approval signals the beginning of our clinical programs in Indonesia and the broader ASEAN region, bringing Recce one step closer to commercialization. We look forward to evaluating R327G in our first Phase 3 trial.” The trial will be conducted as a double-blinded, placebo-controlled study evaluating R327G for the treatment of DFIs and is on track to begin mid-December and aims to enroll up to 300 patients, with 200 to receive R327G and 100 to receive placebo. The trial will run for approximately 12 months, with an expected read-out in late 2025 and regulatory approval and commercial launch in H1 2026. The study is made possible thanks to the significant support of key Indonesian stakeholders, including the Indonesian Ministry of Health, Badan POM, PT Etana Biotechnologies, and the Australian government, accelerating R327G’s path to commercialization. The study will cost Recce around $2M before further subsiding by the Australian government’s 43.5% R&D rebate scheme under the Company’s Advanced Overseas Advanced Finding status with AusIndustry. All intellectual property is that of Recce. Indonesia’s clinical trial approval process involves two key steps: ethics approval (now approved) and BPOM (expected to follow imminently). Completing this trial would enable Recce to replicate regulatory approval for R327G across the broader ASEAN region, including Malaysia, the Philippines, Singapore, and Thailand, as a treatment for DFIs, addressing a critical unmet need for new therapeutics in countries facing increasing rates of antimicrobial resistance and infectious diseases. The trial will be initially conducted at PT Siloam International Hospitals, the largest private hospital network that provides health service facilities in hospitals and clinics in various cities across Indonesia. This approval to commence dosing the registrational Phase 3 trial in DFIs follows a 100% patient response rate in an ongoing Phase 2 study for acute bacterial skin and skin structure infections (ABSSSI) in Australia, showing all patient infections were cured/improved with R327G treatment. The risk of a person with diabetes developing a foot ulcer has been estimated to be as high as 34%.1 Approximately 50% of all diabetic foot ulcers develop infection, which can lead to sepsis, gangrene, amputation, and death.2 The DFI treatment market is estimated to be worth ~$5.2 billion.3 Initially targeting the Indonesian market, which is anticipated to be worth ~$189 million, where diabetes impacts 11% of the population each year.4 Indonesian approvals would provide access to the broader Asia Pacific market worth ~$1.0 billion annually.5 About Recce Pharmaceuticals LtdRecce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens. Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 (R327) as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including their superbug forms; RECCE® 435 (R435) as an orally administered therapy for bacterial infections; and RECCE® 529 (R529) for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics. The World Health Organization (WHO) added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development. Recce wholly owns its automated manufacturing, supporting current clinical trials. Recce’s anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies. Corporate ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 9256 2571James.graham@recce.com.au Media & Investor Relations (AU)Andrew GeddesSeed Media+61 (02) 9267 4511andrew@seedmedia.com.au Media (USA)Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Investor Relations (USA & EU)Guillame van RenterghemLifeSci Advisorsgvanrenterghem@lifesciadvisors.com 1 The Diabetic Foot NCBI2 Up to Date Evaluation of the diabetic foot3 Grand View Research, Diabetic Foot Ulcer Treatment Market Size, 20234 Diabetes Atlas, International Diabetic Federation and Prof EM Yunir, Faculty of Medicines, University of Indonesia5 Business Market Insights, Asia Pacific Diabetic Foot Ulcer Market, 2021

-Lexicon to receive an upfront payment of $25 million and the potential for contingent regulatory and commercial milestone paymentsTHE WOODLANDS, Texas, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Viatris Inc. (Nasdaq: VTRS) has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the United States and Europe in all indications. Lexicon retains sole commercialization rights for sotagliflozin in all indications in the United States and Europe. Sotagliflozin was approved by the U.S. Food and Drug Administration in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. “We are pleased to be working with Viatris, a company with strong cardiometabolic expertise, global commercial capabilities and a successful track record of launching medicines in new territories. We are confident that this agreement will expand the reach of sotagliflozin to more patients in need,” said Dr. Mike Exton, Ph.D., chief executive officer and director of Lexicon. “Partnering with high quality companies to support commercialization of our medicines globally is a critical pillar of our Lead to Succeed strategy at Lexicon. We plan to continue to evaluate strategic partnerships for additional assets, territories and indications to augment Lexicon’s development and commercial capabilities, advance our pipeline and expand access of our medicines to more patients around the world.” Viatris chief commercial officer Corinne Le Goff said: “This licensing agreement with Lexicon adds another asset to our expanding innovative portfolio in cardiovascular diseases which gives us the opportunity to further drive accelerated and durable revenue growth in the future. We believe we will be able to leverage our strong foundation in cardiovascular diseases and our unique infrastructure to execute on the potential of sotagliflozin. We look forward to working with Lexicon to make a real difference and expand access for patients.” Under the terms of the agreement, Viatris has acquired rights to sotagliflozin in all global markets outside of the U.S. and Europe in exchange for an upfront payment to Lexicon of $25 million, and the potential for contingent regulatory and sales milestone payments and tiered royalties ranging from low-double-digit to upper-teens on annual net sales. Viatris will be responsible for all regulatory and commercialization activities for sotagliflozin in the licensed territories. Lexicon will be responsible for providing clinical and commercial supply of sotagliflozin to Viatris at an agreed upon transfer price. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon is commercially launching one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com. About ViatrisViatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, Viatris provides access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life’s moments, from birth to the end of life, acute conditions to chronic diseases. With its exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world’s most enduring health challenges, access takes on deep meaning at Viatris. Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with Viatris on LinkedIn, Instagram, YouTube and X (formerly Twitter). About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. INDICATION INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:  heart failure or  type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors  IMPORTANT SAFETY INFORMATION  Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA.  INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.  Contraindications: INPEFA is contraindicated in patients with hypersensitivity to INPEFA or any of its components.  Ketoacidosis: INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM).  Type 2 diabetes Mellitus (T2DM) and pancreatic disorders are also risk factors.  The risk of ketoacidosis may be greater with higher doses.  There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors.  Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis and educate patients on the signs/symptoms of ketoacidosis.  Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.  INPEFA is not indicated for glycemic control.  Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level.  If suspected, discontinue INPEFA, evaluate, and treat promptly.  Monitor patients for resolution of ketoacidosis before restarting INPEFA.  Volume Depletion: INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine.  There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors.  Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension.  Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy.  Urosepsis and Pyelonephritis: Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections.  Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.  Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia.  INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue.  Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA. Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Reports of Fournier’s Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors.  Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement.  Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.  Genital Mycotic Infections: INPEFA increases the risk of genital mycotic infections.  Monitor and treat as appropriate.  Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable for patients taking SGLT2 inhibitors.  Use alternative testing methods to monitor glucose levels.   Common Adverse Reactions: the most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.  Drug Interactions:  Digoxin: Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg. Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer: The coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin.   Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations.  Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes.  Use in Specific Populations:  Pregnancy and Lactation: INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding.  Geriatric Use: No INPEFA dosage change is recommended based on age.  No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.  Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension.Renal Impairment: INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m2) and in patients with heart failure with eGFR < 60 mL/min/1.73 m2.  The safety profile of INPEFA across eGFR subgroups in these studies was consistent with the known safety profile.  There was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with eGFR < 30 mL/min/1.73m2 relative to the overall safety population.  Efficacy and safety studies with INPEFA did not enroll patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis.  After starting therapy in the studies, patients were discontinued if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic dialysis.Hepatic Impairment: INPEFA is not recommended in patients with moderate or severe hepatic impairment. Click here for full Prescribing Information. https://www.lexpharma.com/inpefa-US-PI.pdf Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize INPEFA in heart failure on the timeline and/or at the prices currently contemplated or at all, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin (in other indications), LX9211, LX9851 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Media and Investor Inquiries: Lisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com