Latest news with #CumberlandPharmaceuticals
Yahoo
13-05-2025
- Business
- Yahoo
CUMBERLAND PHARMACEUTICALS PARTNERS WITH QUREIGHT TO ADVANCE INNOVATIVE IDIOPATHIC PULMONARY FIBROSIS TREATMENT RESEARCH
Cumberland leveraging Qureight's deep-learning AI platform for its Phase II FIGHTING FIBROSIS™ clinical trial NASHVILLE, Tenn. and CAMBRIDGE, England, May 13, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company with development efforts focused on new products for rare diseases, today announced a partnership with Qureight, a Core Imaging Laboratory developing deep-learning image analytics, to enhance the outcome and output of data from Cumberland's FIGHTING FIBROSIS™ clinical trial. The Phase II study is evaluating Cumberland's ifetroban product candidate in patients with idiopathic pulmonary fibrosis (IPF), the most common form of progressive fibrosing interstitial lung disease. This collaboration aims to address a critical unmet need for the estimated 2 million IPF patients worldwide, who currently have limited treatment options that can effectively halt disease progression. The partnership will utilize Qureight's advanced, deep-learning image analytics tools for complex lung disease applications to provide deeper insights into treatment efficacy and disease progression in Cumberland's IPF clinical program. Under this partnership, Qureight's AI-driven analytics technologies will be used to quantify changes in multiple imaging biomarkers, using computed tomography (CT) data from FIGHTING FIBROSIS™ study patients. Qureight's quantitative deep learning-based tools will precisely measure changes in the volume of patients' fibrotic, vascular and airway lung compartments, allowing a more detailed investigation of ifetroban's modulation of both lung structure and function. The collaboration leverages Qureight's expertise in IPF and quantitative imaging biomarkers to support Cumberland's evaluation of crucial primary and secondary study endpoints. "We are excited to partner with Qureight as we work to develop a new treatment for patients with IPF – and address that critical unmet medical need," said A.J. Kazimi, Cumberland Pharmaceuticals Chief Executive Officer. "Given ifetroban's promising data demonstrating prevention of lung fibrosis in multiple preclinical models, we believe Qureight's advanced imaging analysis capabilities will provide crucial insights that could help advance understanding and outputs from our IPF clinical program." Cumberland's FIGHTING FIBROSIS™ clinical trial is a multicenter, double-blind, placebo-controlled Phase II study investigating the safety and efficacy of once daily oral ifetroban for 52 weeks in patients with IPF. The study includes both patients on existing antifibrotic therapies and those not currently receiving such treatments, with a primary endpoint focusing on change in forced vital capacity. "We are thrilled to partner with Cumberland Pharmaceuticals on this important clinical trial," said Dr. Muhunthan Thillai, Chief Executive Officer at Qureight. "Their innovative approach in treating IPF patients for 12 months at this development stage, allows for a truly meaningful assessment of ifetroban's efficacy and tolerability – the characteristics of treatment that IPF patients so urgently need. When combined with our AI image analytics technologies, the resulting data has the potential to significantly deepen our understanding of how to quantify treatment effects in this complex and devastating disease." "The application of AI-driven quantitative imaging in IPF clinical research marks a significant step forward in how we evaluate treatment response," said Phil Molyneaux, MD, Professor of Pulmonary Medicine at the Royal Brompton Hospital, London. "By enabling precise measurement of changes in fibrotic, vascular and airway compartments of the lung, this approach offers insights beyond what traditional pulmonary function tests can provide—potentially allowing us to accelerate the development of urgently needed therapies for patients with IPF." Both Cumberland and Qureight will be attending the upcoming American Thoracic Society International Conference in San Francisco, where the FIGHTING FIBROSIS™ study will be featured in the Clinical Trial Awareness area. This collaborative presence at one of the world's premier respiratory medicine gatherings underscores the companies' shared commitment to advancing innovative solutions for patients with pulmonary fibrosis. About Idiopathic Pulmonary FibrosisIdiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease marked by inflammation and fibrosis of the lungs, resulting in rapidly declining lung function and reduced survival within five years of diagnosis. IPF is the most common form of interstitial lung disease and affects up to 2 million individuals globally. While FDA-approved antifibrotic therapies have shown efficacy to slow progression of the disease, there is no approved treatment which effectively halts disease progression and improves patients' symptoms. Therefore, an unmet need exists to identify additional treatments which add benefit and provide alternatives to existing therapies. About The FIGHTING FIBROSIS™ Clinical TrialThe FIGHTING FIBROSIS™ clinical trial is a double-blind, placebo-controlled Phase II study designed to evaluate 12 months of oral ifetroban and enroll 128 patients in over 20 medical centers of excellence across the U.S. The study is currently actively enrolling at 16 centers. The clinical trial is registered on under identifier NCT05571059. For more information about the study, including eligibility criteria and participating sites, please visit or contact Ingrid Anderson, PhD at ianderson@ or 615-556-7188. About IfetrobanIfetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. Ifetroban exhibits high affinity for TPr on many cell types including platelets, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. Ifetroban also displays anti-platelet, antivasospastic, antifibrotic, and antibronchospastic activities and is effective in certain preclinical models of vasospasm, thrombosis, reperfusion injury, cardiac fibrosis, lung fibrosis and endothelial dysfunction, including models that are insensitive to aspirin. Cumberland acquired the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies (CET). Cumberland is also sponsoring the FIGHT DMD™ trial, a multicenter, randomized, placebo-controlled Phase II study evaluating two doses of oral ifetroban for the treatment of the cardiomyopathy associated with Duchenne muscular dystrophy, and has a Phase II clinical program for Systemic Sclerosis. About Cumberland PharmaceuticalsCumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections. For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, which can be found on the company's website: About QureightFounded in 2018 and headquartered in Cambridge, UK, Qureight is a Core Imaging Laboratory, a rapidly-scaling techbio company deploying its technology on a global scale. The cloud-based, vendor-agnostic Core Imaging Platform is GDPR, HIPPA and NHS Digital compliant. The platform has ISO13485 and ISO27001 accreditation to interrogate clinical trial data. The team is led by co-founder & CEO Dr Muhunthan Thillai, a pulmonologist who trained in lung fibrosis. Forward-Looking StatementsThis press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. View original content to download multimedia: SOURCE Cumberland Pharmaceuticals Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
12-03-2025
- Health
- Globe and Mail
Burn Pain Market to Reach New Heights in Growth by 2034, DelveInsight Predicts
The Key Burn Pain Companies in the market include - Medical Developments International, Cumberland Pharmaceuticals, Janssen Research & Development, Cephalon, and others. DelveInsight's 'Burn Pain Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Burn Pain, historical and forecasted epidemiology as well as the Burn Pain market trends in the United States, EU4 (Germany, Spain, Italy, France, and United Kingdom) and Japan. Some of the key facts of the Burn Pain Market Report: The Burn Pain market size is anticipated to grow with a significant CAGR during the study period (2020-2034) In August 2024, MediWound Ltd. (Nasdaq: MDWD), a global leader in enzymatic therapeutics for tissue repair, announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for eschar removal in pediatric patients from newborns to 18 years old with deep partial- and full-thickness thermal burns. This approval expands NexoBrid's authorization for all age groups in the U.S., aligning with its approvals in the European Union and Japan. In 2023, the US maintained the largest market share among the 7MM, reaching USD 140 million. Projections indicate that this trend will persist, with the US expected to further strengthen its market dominance and remain the leading player by 2034. In 2023, Germany and the UK in the EU4 and the UK both achieved market shares exceeding USD 20 million, with France following closely behind. In contrast, Italy had the smallest market share among these regions during the same period. Opioid analgesics dominated the current treatment market for both inpatient and outpatient care, with an estimated market value of approximately USD 130 million in 2023. In 2023, the US recorded over 2 million incident cases of burns, with numbers expected to rise by 2034. In 2023, approximately 0.4 million treated incident burn cases requiring pain management therapies were reported in the US, with expectations for change during the study period from 2020 to 2034. The gender distribution indicates a male dominance across the 7MM, with around 0.29 million male cases and 0.26 million female cases reported in the US in 2023. Key Burn Pain Companies: Medical Developments International, Cumberland Pharmaceuticals, Janssen Research & Development, Cephalon, and others Key Burn Pain Therapies: Methoxyflurane (PENTHROX), Caldolor, JNJ-42160443, ACTIQ, and others The Burn Pain epidemiology based on etiology-specific cases analyzed that Etiology Specific Incident Cases of Burns is classified into Flame, Contact, Scald, Electrical, Chemical, and Others The Burn Pain market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Burn Pain pipeline products will significantly revolutionize the Burn Pain market dynamics. Burn Pain Overview An organic tissue injury known as a burn is mostly brought on by heat, radiation, radioactivity, electricity, friction, or chemical contact. Get a Free sample for the Burn Pain Market Report - Burn Pain Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Burn Pain Epidemiology Segmentation: The Burn Pain market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalence of Burn Pain Prevalent Cases of Burn Pain by severity Gender-specific Prevalence of Burn Pain Diagnosed Cases of Episodic and Chronic Burn Pain Download the report to understand which factors are driving Burn Pain epidemiology trends @ Burn Pain Epidemiology Forecast Burn Pain Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Burn Pain market or expected to get launched during the study period. The analysis covers Burn Pain market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the Burn Pain Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. Burn Pain Therapies and Key Companies Burn Pain Market Strengths The increasing incidence of patients with burns is expected to propel the treatment market in the future, adding opportunities for new pharma players Burn Pain Market Opportunities The rising incidence of burn pain indicates increasing pharmacological treatment demands, thereby crafting lucrative opportunities for new pharma players Scope of the Burn Pain Market Report Study Period: 2020–2034 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Burn Pain Companies: Medical Developments International, Cumberland Pharmaceuticals, Janssen Research & Development, Cephalon, and others Key Burn Pain Therapies: Methoxyflurane (PENTHROX), Caldolor, JNJ-42160443, ACTIQ, and others Burn Pain Therapeutic Assessment: Burn Pain current marketed and Burn Pain emerging therapies Burn Pain Market Dynamics: Burn Pain market drivers and Burn Pain market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Burn Pain Unmet Needs, KOL's views, Analyst's views, Burn Pain Market Access and Reimbursement Table of Contents 1. Burn Pain Market Report Introduction 2. Executive Summary for Burn Pain 3. SWOT analysis of Burn Pain 4. Burn Pain Patient Share (%) Overview at a Glance 5. Burn Pain Market Overview at a Glance 6. Burn Pain Disease Background and Overview 7. Burn Pain Epidemiology and Patient Population 8. Country-Specific Patient Population of Burn Pain 9. Burn Pain Current Treatment and Medical Practices 10. Burn Pain Unmet Needs 11. Burn Pain Emerging Therapies 12. Burn Pain Market Outlook 13. Country-Wise Burn Pain Market Analysis (2020–2034) 14. Burn Pain Market Access and Reimbursement of Therapies 15. Burn Pain Market Drivers 16. Burn Pain Market Barriers 17. Burn Pain Appendix 18. Burn Pain Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Contact Person: Gaurav Bora Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Yahoo
05-02-2025
- Business
- Yahoo
Cumberland Pharmaceuticals reports data from trial of ifetroban for DMD
US-based pharmaceutical company Cumberland Pharmaceuticals has reported positive top-line outcomes from a Phase II trial of ifetroban as a potential treatment for Duchenne muscular dystrophy (DMD). A total of 41 subjects with DMD were enrolled in the double-blind, placebo-controlled FIGHT DMD trial, which lasted 12 months. Subjects received either a daily dose of either 100mg (low dose) or 300mg (high dose) of the oral thromboxane receptor antagonist ifetroban or a placebo. Improvement in the heart's left ventricular ejection fraction (LVEF) was the trial's primary endpoint. The results showed that high-dose treatment of the therapy led to a 3.3% overall improvement in LVEF. The high-dose arm experienced a 1.8% increase in LVEF, against a 1.5% decline in the placebo arm. Compared with propensity-matched natural history controls, the high-dose treatment showed an overall improvement of 5.4%, as control subjects reported a decline of 3.6% in LVEF. Both doses of the therapy were observed to be well-tolerated, without any serious drug-related events. Ifetroban functions by blocking a receptor involved in inflammation and fibrosis, and has received orphan drug and rare paediatric disease statuses from the Food and Drug Administration (FDA). If approved, the drug is expected to become the first therapy specifically indicated for DMD-related heart disease. Cumberland Pharmaceuticals CEO AJ Kazimi said: 'As the first company to receive FDA orphan products development funding for a DMD clinical trial, we're honoured to be advancing a potential breakthrough therapy for DMD-related heart disease. 'These results validate our commitment to developing innovative treatments for rare diseases and underscore the importance of collaborative partnerships between industry, academia, and regulatory agencies in addressing critical unmet medical needs.' Based in Tennessee, Cumberland Pharmaceuticals develops, acquires and commercialises products for hospital acute care, gastroenterology and oncology. In May 2023, the company announced plans to launch the Phase II FIGHTING FIBROSIS trial of ifetroban for idiopathic pulmonary fibrosis (IPF). "Cumberland Pharmaceuticals reports data from trial of ifetroban for DMD" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
