A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study With a Long-Term, Open-Label Extension to Evaluate the Efficacy and Safety of TRM-201 (Rofecoxib) in Patients With Hemophilic Arthropathy

This is a multicenter, randomized, double-blind study to evaluate the efficacy and safety of TRM-201 (rofecoxib) versus Placebo in the treatment of patients with hemophilic arthropathy (HA) over a 12-week period (Part I) that is followed by a year-long (52 week) open-label extension (Part II) to further evaluate the safety and maintenance of efficacy of TRM-201.

Start Date02 Jun 2021

Sponsor / Collaborator

Tremeau Pharmaceuticals, Inc.Startup

NCT00165048 / Unknown statusPhase 3IIT

Selective COX-II Inhibitor as a Palliative Therapy in Patients With R1 or R2 Resection for Disseminated Stomach Cancer - A Multi-Centre Prospective Randomized Controlled Trial

The purpose of this study is to investigate the effect of selective COX-II inhibitor in patients with regionally disseminated stomach cancer treated by palliative resection (so called R1 or R2 gastrectomy).

Start Date01 Oct 2004

Sponsor / Collaborator

The Chinese University of Hong Kong

NCT00164892 / Unknown statusPhase 3IIT

Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial

The purpose of this study is to investigate the efficacy of selective COX-II inhibitor in patients with curative resection performed for locally advanced stomach cancer.

Start Date01 Oct 2004

Sponsor / Collaborator

The Chinese University of Hong Kong

100 Clinical Results associated with Rofecoxib

100 Translational Medicine associated with Rofecoxib

100 Patents (Medical) associated with Rofecoxib

2,505

Literatures (Medical) associated with Rofecoxib

01 Dec 2024·FOOD AND CHEMICAL TOXICOLOGY

RIFM fragrance ingredient safety assessment, 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone, CAS Registry number 61315-75-1

Article

Author: Crotty, S. ; Fryer, A.D. ; Bryant-Friedrich, A. ; Burton, G A ; Laskin, D.L. ; Botelho, D. ; Botelho, D ; Chon, H ; Schember, I ; Bryant-Friedrich, A ; Lee, I. ; Sipes, I.G. ; Dekant, W. ; Thakkar, Y ; Joshi, K. ; Laskin, D L ; Bruze, M ; Belsito, D ; Chon, H. ; Thakkar, Y. ; Moustakas, H ; Lavelle, M ; Piersma, A H ; Dekant, W ; Ritacco, G. ; Crotty, S ; Moustakas, H. ; Burton, G.A. ; Sadekar, N. ; Bruze, M. ; Farrell, K ; Sullivan, G ; Api, A.M. ; Cronin, M. ; Ritacco, G ; Schultz, T.W. ; Dagli, M L ; Jones, L. ; Belsito, D. ; Farrell, K. ; Joshi, K ; Schultz, T W ; Muldoon, J. ; Lapczynski, A ; Penning, T M ; Cancellieri, M.A. ; Cancellieri, M A ; Deodhar, C ; Muldoon, J ; Bartlett, A. ; Sipes, I G ; Lavelle, M. ; Cronin, M ; Deodhar, C. ; Dagli, M.L. ; Lapczynski, A. ; Schember, I. ; Penning, T.M. ; Lee, I ; Fryer, A D ; Sullivan, G. ; Siddiqi, F ; Jones, L ; Bartlett, A ; Piersma, A.H. ; Api, A M ; Sadekar, N ; Siddiqi, F.

The existing information supports the use of this material as described in this safety assessment. 4-(4-Methyl-3-penten-1-yl)-2(5H)-furanone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is not mutagenic. The clastogenicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for the genotoxicity endpoint material, and the exposure to 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is below the TTC (0.0025 μg/kg/day). The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class III material, and the exposure to 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for reactive materials (64 μg/cm²); exposure is below the DST. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; for the hazard assessment based on the screening data, 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is not Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. For the risk assessment, 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone was not able to be risk screened as there were no reported volumes of use (VoU) for either North America or Europe in the 2019 IFRA Survey.

09 Sep 2024·CLINICAL ORTHOPAEDICS AND RELATED RESEARCH

Which Interventions Are Effective in Treating Sleep Disturbances After THA or TKA? A Systematic Review.

Article

Author: Cyrus, John W ; Brauer, Sarah F ; Patel, Nirav K ; Bankuru, Sri Vibhaav ; Pilc, Emily

BACKGROUND:

Poor sleep quality is a common complaint after total joint arthroplasty (TJA), and it is associated with reports of higher pain and worse functional outcomes. Several interventions have been investigated with the intent to reduce the incidence of postoperative sleep disturbance with varying effectiveness. An aggregate of the best available evidence, along with an evaluation of the quality of those studies, is needed to provide valuable perspective to physicians and to direct future research.

QUESTIONS/PURPOSES:

In this systematic review, we asked: (1) What is the reported efficacy of the most commonly studied medications and nonpharmacologic approaches, and (2) what are their side effects and reported complications?

METHODS:

This systematic review was conducted in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A search using a combination of controlled vocabulary and keywords was performed utilizing Medline (Ovid), Embase (Ovid), Cochrane Central, and Web of Science databases from database inception to 2023, with the last search occurring October 24, 2023, to identify studies that evaluated a sleep intervention on the effect of patient-reported sleep quality after THA or TKA. Inclusion criteria were clinical trials, comparative studies, and observational studies on adult patients who underwent primary TKA or THA for osteoarthritis and who completed validated sleep questionnaires to assess sleep quality postoperatively. We excluded studies on patients younger than 18 years, patients with sleep apnea, TKA or THA because of trauma or conditions other than osteoarthritis, revision TJA, studies in languages other than English, and studies from nonindexed journals or preprint servers. Two investigators independently screened 1535 studies for inclusion and exclusion criteria and extracted data from the included studies. Ultimately, 14 studies were included in this systematic review, including 12 randomized controlled trials and 2 prospective comparative studies. A total of 2469 participants were included, with a mean ± SD age of 65 ± 7 years and 38% men in control groups and 65 ± 7 years and 39% men in intervention groups. Sleep quality questionnaires utilized included the Pittsburgh Sleep Quality Index, Self-Rating Scale of Sleep, 100-mm VAS - Sleep, Sleep Disturbance Numeric Rating Scale, Likert scales, and one institutionally designed questionnaire. Quality analysis was performed utilizing the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Randomized Controlled Trials, where higher scores of 13 indicated a more reliable study, and the Newcastle-Ottawa Quality Assessment Scale for Cohort Studies, where higher scores of 9 indicated a more reliable study and scores < 5 represented a high risk of bias. Two of the randomized controlled trials scored a 12 of 13, and the remaining 10 met every criteria of the JBI checklist. Both comparative studies scored 5 of 9 possible points of the Newcastle-Ottawa Scale.

RESULTS:

Melatonin and selective cyclooxygenase-2 inhibitor rofecoxib were found to provide a clinically important benefit to sleep quality within the first postoperative week after TJA. However, rofecoxib was withdrawn from the market globally in 2004 over concerns about increased risk of cardiovascular events. Another cyclooxygenase-2 inhibitor, celecoxib, remains available. No other intervention demonstrated a clinical benefit. Side effects of melatonin include dizziness, headache, paresthesia, and nausea, and it is contraindicated in patients with liver failure, autoimmune conditions, or who are receiving warfarin. Long-term adverse effects of rofecoxib include hypertension, edema, and congestive heart failure, and it is contraindicated in patients with renal insufficiency or who are receiving warfarin. Melatonin is considered safe in older patients, but more caution should be taken with rofecoxib.

CONCLUSION:

Owing to limited evidence in support of most of the interventions we studied, none of these interventions can be recommended for routine use after TJA. Melatonin and rofecoxib may provide a benefit to sleep quality in some patients, but physicians need to understand the adverse effects and contraindications before recommending these interventions. Additionally, rofecoxib is no longer commercially available. Future investigation is warranted to evaluate the effectiveness of interventions with minimal side effect profiles for providers to be able to make an informed decision about interventions for sleep improvement after TJA.

LEVEL OF EVIDENCE:

Level III, therapeutic study.

06 Aug 2024·ACS Omega

New Diaryl-1,2,4-triazolo[3,4-a]pyrimidine Hybrids as Selective COX-2/sEH Dual Inhibitors with Potent Analgesic/Anti-inflammatory and Cardioprotective Properties

Article

Author: Youssif, Bahaa G. M. ; El-Adl, Khaled ; Al-Wahaibi, Lamya H. ; Abdel-Aziz, Salah A. ; Abdel-Rahman, Mostafa H. ; Bräse, Stefan

COX-2-selective drugs were withdrawn from the market just a few years after their development due to cardiovascular side effects. As a result, developing a selective COX-2 inhibitor as an anti-inflammatory agent with cardioprotective characteristics has become a prominent objective in medicinal chemistry. New 15 diaryl-1,2,4-triazolo[3,4-a]pyrimidine hybrids 8a-o were synthesized and investigated in vitro as dual COX-2/sEH inhibitors. Compounds 8b, 8m, and 8o have the highest potency and selectivity as COX-2 inhibitors (IC₅₀ = 15.20, 11.60, and 10.50 μM, respectively; selectivity index (COX-1/COX-2) = 13, 20, and 25, respectively), compared to celecoxib (COX-2; IC₅₀ = 42 μM; SI = 8). The 5-LOX inhibitory activity of compounds 8b, 8m, and 8o was further examined in vitro. Compounds 8m and 8o, the most effective COX-2 selective inhibitors, demonstrated stronger 5-LOX inhibitory action than the reference quercetin, with IC₅₀ values of 2.90 and 3.05 μM, respectively. Additionally, compounds 8b, 8m, and 8o were the most potent dual COX-2/sEH inhibitors, with IC₅₀ values against sEH of 3.20, 2.95, and 2.20 nM, respectively, and were equivalent to AUDA (IC₅₀ = 1.2 nM). In vivo investigations also demonstrated that these compounds were the most efficacious as analgesic/anti-inflammatory derivatives with a high cardioprotective profile against cardiac biomarkers and inflammatory cytokines. The docking data analysis inquiry helped better understand the binding mechanisms of the most active hybrids within the COX-2 active site and supported their COX-2 selectivity. Compounds 8b, 8m, and 8o exhibited a similar orientation to rofecoxib and celecoxib, with a larger proclivity to enter the selectivity side pocket than the reference compounds.

News (Medical) associated with Rofecoxib

02 Apr 2024

·www.prnewswire.com

Jayne Conroy of Simmons Hanly Conroy Named to the Plaintiffs' Executive Committee in Insulin Price Fixing Multidistrict Litigation in District of New Jersey

ALTON, Ill. and NEW YORK, April 2, 2024 /PRNewswire/ -- Simmons Hanly Conroy, one of the nation's leading mass tort litigation firms dedicated to holding corporations responsible for wrongdoing, today announced that attorney and Named Partner Jayne Conroy has been appointed to the Plaintiffs' Executive Committee (PEC) for the Insulin Price Fixing Multidistrict Litigation (MDL) in the United States District Court of the District Of New Jersey. District Judge Brian R. Martinotti will oversee the three main cases of the litigation. The litigation involves plaintiffs who say three of the largest pharmaceutical companies in the world, Eli Lilly and Co., Novo Nordisk Inc., and Sanofi-Aventis U.S. LLC, artificially inflated the prices of lifesaving insulin in order to profit at the expense of the health and livelihood of individuals with diabetes or prediabetes in communities across the United States. "The drug and pharmacy benefit manufacturers involved in this case have upheld and perpetuated dangerous and deceptive drug pricing practices that have put many lives at risk across the nation," said Jayne Conroy, Named Partner at Simmons Hanly Conroy. "I am honored to be selected to the Plaintiffs' Executive Committee of such a pivotal suit for insulin users and their communities. This suit seeks to secure accountability against these corporations, ensure the wellbeing of affected individuals in the near and long term, and bring an end to the predatory pricing of insulin." Conroy oversees Simmons Hanly Conroy's Complex Litigation Department. Under her leadership, Simmons Hanly Conroy has become one of the country's largest plaintiff law firms dedicated to helping those injured by corporate wrongdoing. Conroy has helped secure billions of dollars in verdicts and settlements for thousands of individuals, families, and communities across the country. With more than three decades of legal experience, she focuses her practice on helping plaintiffs exclusively in mass torts, class actions, product liability, pharmaceutical and sexual abuse litigation. Conroy serves or has served on dozens of court-appointed leadership committees in complex legal actions of national scope. Conroy also serves as co-lead of the National Prescription Opiate Multidistrict Litigation in the Northern District of Ohio, and as co-lead and interim class counsel representing plaintiffs in the case against Norfolk Southern, the company responsible for the Feb. 3, 2023 East Palestine, Ohio train derailment. Additionally, she has served on the Plaintiffs' Executive Committee of the Camp Lejeune Contaminated Water Litigation. Since its inception, Simmons Hanly Conroy has successfully helped thousands of clients across the country harmed by corporate wrongdoing. About Simmons Hanly Conroy, LLP Simmons Hanly Conroy, with nearly 250 employees, including more than 100 attorneys practicing nationwide, is one of the country's largest plaintiff law firms dedicated to holding corporations responsible for wrongdoing. Primary areas of litigation include mesothelioma and asbestos, pharmaceutical and medical device injuries, consumer protection class actions, environmental injuries and protection, and complex personal injury. The firm's attorneys have been appointed to leadership in numerous national multidistrict litigations, including prescription opioids, Vioxx, Toyota unintended acceleration, BP Deepwater Horizon Oil Spill, DePuy Pinnacle and the Volkswagen emission scandal. Since 1999, the firm has secured $10.2 billion in verdicts and settlements for thousands of clients nationwide and is a major supporter of asbestos-related cancer research. Offices are located in Alton, Ill.; Los Angeles; New York City; San Francisco; and St. Louis. Read more at . Media Contact: [email protected] SOURCE Simmons Hanly Conroy

Patent InfringementExecutive Change

16 Nov 2023

·www.biopharmadive.com

Top FDA official Woodcock to retire early next year

Janet Woodcock, a top Food and Drug Administration official who had been on the short list to head the agency under President Joe Biden, will retire in early 2024 after 37 years at the regulator.Her retirement, first reported by Endpoints, was announced in an agency-wide message from Commissioner Robert Califf.A legend in every sense of the word, Janet has made an indelible mark on so many of us, and on public health, the announcement read. There isnt enough space or time here to properly capture her accomplishments, sing her praises, and most of all, thank her.Woodcock had served as acting commissioner at the beginning of the Biden administration until Califf assumed office in February 2022. At one time she was seen as a leading candidate to assume the full-time commissioners role, but some senators opposed her over her role in approving opioid painkillers while heading the FDAs drug review branch.During her tenure as acting FDA commissioner, the agency also signed off on the Alzheimers disease drug Aduhelm, despite the conflicting evidence presented by its developer, Biogen, in support of approval, as well as negative opinions from the agencys own statisticians and outside advisers.The decision was reminiscent of another approval that was made while Woodcock was head of the FDAs Center for Drug Evaluation and Research: the controversial call to approve Sarepta Therapeutics Duchenne muscular dystrophy drug Exondys over a negative vote from expert advisers convened to review that drug.Woodcock joined the FDA in 1986, first having several roles at the agencys Center for Biologics Evaluation and Research, which regulates vaccines, blood products and products derived from living tissues like cell and gene therapies. In 1994, she joined the drug evaluation and review division as director. During her time there, dozens of drugs gained approval that have extended patients lives or helped them control symptoms, while others, like the pain reliever Vioxx and the diabetes pill Avandia, proved to be unsafe.In 2004, she joined the commissioners office, serving as deputy commissioner, chief medical officer and chief operating officer. She returned to drug evaluation in 2007, where she served until the COVID-19 pandemic. She moved to the White Houses Operation Warp Speed, where she was in charge of evaluating therapeutics to treat COVID-19 infections.Since Califf assumed the commissioners position, Woodcock has served as his principal deputy commissioner. '

Executive Change

02 Nov 2023

·www.biospace.com

Arrowhead Pharmaceuticals to Present New Phase 2 Clinical Data on Cardiometabolic Pipeline at AHA 2023

Company will also host a virtual analyst and investor event on November 13, 2023 PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it will present new Phase 2 clinical data from the ongoing SHASTA-2 and MUIR studies of plozasiran (ARO-APOC3) and the ARCHES-2 study of zodasiran (ARO-ANG3) at the American Heart Association (AHA) Scientific Sessions 2023, being held in Philadelphia on November 11-13, 2023. The company will also host a virtual analyst and investor event on November 13, 2023, at 4:30 pm ET featuring key opinion leaders who will discuss these data and their relevance as potential treatments for severe hypertriglyceridemia and mixed dyslipidemia in patients with atherosclerotic cardiovascular disease (ASCVD). To register for the event, please visit: . Details about the AHA presentations are listed below. American Heart Association (AHA) Scientific Sessions 2023 – November 11-13, 2023 Title: ARO-APOC3, an Investigational RNAi Therapeutic, Silences APOC3 and Reduces Triglycerides to Near Normal Levels in Patients With Severe Hypertriglyceridemia: SHASTA-2 Study Results Date/Time: November 13, 2023, 9:45 a.m. EST Presenter: Daniel Gaudet Session: Lipid Lowering via Novel Pathways Title: ARO-APOC3, an Investigational RNAi Therapeutic, Silences APOC3 and Reduces Atherosclerosis-Associated Lipoproteins in Patients With Mixed Dyslipidemia: MUIR Study Results Date/Time: November 13, 2023, 1:30 p.m. EST Presenter: Christie M Ballantyne Session: Emerging Approaches to Lipid Lowering Title: ARO-ANG3, an Investigational RNAi Therapeutic, Silences the Expression of ANGPTL3 and Decreases Atherogenic Lipoproteins in Patients With Mixed Dyslipidemia: ARCHES-2 Study Results Date/Time: November 13, 2023, 1:30 p.m. EST Presenter: Robert S Rosenson Session: Emerging Approaches to Lipid Lowering The analyst and investor event will feature presentations from Arrowhead management and three experts in the treatment and management of lipid and lipoprotein disorders: Daniel Gaudet, MD, PhD, Professor of Medicine at Université de Montréal, who will discuss plozasiran in the context of the current treatment landscape for severe hypertriglyceridemia Børge Nordestgaard, MD, Professor & Chief Physician, Copenhagen University Hospital, University of Copenhagen, Denmark, who will discuss remnant cholesterol and its role in cardiovascular disease Steven Nissen, MD, Chief Academic Officer for the Heart and Vascular Institute at the Cleveland Clinic, who will discuss the potential of a cardiovascular outcomes study of plozasiran Expert Bios Daniel Gaudet, MD, PhD, is Professor of Medicine at Université de Montréal (UdeM) and leads the UdeM Community Genetic Medicine Center and its Clinical Lipidology and Rare Lipid Disorders Unit. He is currently president and scientific director of ECOGENE-21, a non-for profit organization devoted to access to innovation in precision medicine. His main clinical and academic activities aim at investigating rare or severe dyslipidemias and translating new knowledge issued from extreme phenotypes to more common forms of diseases. Over the years, he has coordinated more than 200 clinical studies involving the development of screening tools, technologies or emerging therapies for severe dyslipidemias or related disorders, in collaboration with biotechs, pharmas, or academic partners. He authored more than 320 scientific publications in peer-reviewed journals, including several tens in very highly rated Journals (NEJM, Nature Medicine, Eur Heart J, Lancet, Nature Genetics) as well as >500 scientific communications or book chapters. Børge G. Nordestgaard, MD, DMSc, is Professor & Chief Physician, Copenhagen University Hospital, University of Copenhagen, Denmark, and President-Elect European Atherosclerosis Society. Prof Nordestgaard studied and worked in Copenhagen, New York, and London. He has for more than 30 years continued his interest in the pathogenesis, diagnosis and treatment of familial hypercholesterolemia, hyperlipidemia, lipoprotein(a), atherosclerosis, diabetes and cardiovascular disease, and has written extensively on these conditions. He is chairing the Copenhagen General Population Study and is a steering committee member of the Copenhagen City Heart Study and five phase 3 cardiovascular intervention trials. Prof. Nordestgaard has supervised 74 Ph.D. students and 34 postdoctoral fellows, and has published 920 original articles and 140 reviews, book chapters, consensus statements, & editorials. His H-index is 152 in Web of Science and he is listed among the top 0.1% researchers worldwide with the most highly cited papers. Original articles include publications in New England Journal of Medicine, Lancet, Journal of the American Medical Association, Nature, Science, Nature Genetics, British Medical Journal, Lancet Diabetes Endocrinology, Circulation, European Heart Journal, Journal of the American College of Cardiology and JAMA cardiology. Steven E. Nissen MD is Chief Academic Officer for the Heart and Vascular Institute at the Cleveland Clinic, the Lewis and Patricia Dickey Chair in Cardiovascular Medicine and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. From 2006 to 2019, he served as Chair of the Department of Cardiovascular Medicine at the Cleveland Clinic. In 2006-2007 he served as President of the American College of Cardiology (ACC), the professional society representing American cardiologists. His initial research focused on application of intravascular ultrasound (IVUS) imaging to the assessment of progression and regression of coronary atherosclerosis, conducting more than a dozen randomized controlled trials, most published in the NEJM or JAMA. More recently, he has served as Study Chairman for large global cardiovascular outcomes trials, most studying lipid modifying therapies. His contributions to scientific literature include more than 600 journal articles and 60 book chapters. He is co-author of a book for patients with heart disease, Heart411 released by Crown Books on January 31, 2012. Dr. Nissen works closely with pharmaceutical companies on the development of new therapies for cardiovascular disease, but maintains a longstanding policy of requiring companies to donate all related honoraria directly to charity so that he receives neither income, nor a tax deduction. He has also written extensively on the subject of drug safety. In 2001, he co-authored the first manuscript (JAMA) that raised concerns about the cardiovascular safety of rofecoxib (Vioxx™), which was withdrawn from the market 3 years later. In 2007, he authored a NEJM manuscript that demonstrated that the widely used diabetes drug rosiglitazone (Avandia™) raised the risk of myocardial infarction, eventually leading in 2010 to withdrawal of the drug in Europe and severe restrictions in the US. Dr. Nissen served as a member of the CardioRenal Advisory Panel of Food and Drug Administration (FDA) for 5 years, and Chairman the final year of his membership. He continues to serve as Advisor to several FDA committees as a “Special Government Employee”. In July 2008, while serving as guest member of the Endocrine and Metabolism Advisory Panel, he recommended a new approach for approval of diabetes drugs, which was ultimately adopted by the Agency in December 2008. Dr. Nissen is also known for his role in public policy discussions. He has testified in both the Senate (Health Education and Labor Committee) and House of Representatives (Energy and Commerce Committee) on Food and Drug Administration (FDA) policy. He was actively involved in discussions with Congress on the FDA Amendments Act of 2007 that added additional regulatory authority for the Agency. In 2007, Time Magazine selected Dr. Nissen as one of the world’s 100 most influential people. Beginning in 2015, he was named by Thompson-Reuters as one of the world’s most highly cited physician-scientists. A copy of the presentation materials and a webcast link for the analyst and investor event will be available on the Events and Presentations page under the Investors section of the Arrowhead website. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit , or follow us on Twitter @ArrowheadPharma. To be added to the Company's email list and receive news directly, please visit . Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc. View source version on businesswire.com: Contacts Arrowhead Pharmaceuticals, Inc. Vince Anzalone, CFA 626-304-3400 ir@arrowheadpharma.com Investors: LifeSci Advisors, LLC Brian Ritchie 212-915-2578 britchie@lifesciadvisors.com Media: LifeSci Communications, LLC Jason Braco, Ph.D. 646-751-4361 jbraco@lifescicomms.com Source: Arrowhead Pharmaceuticals, Inc. View this news release online at:

AHA

100 Deals associated with Rofecoxib

External Link

KEGG	Wiki	ATC	Drug Bank
D00568	Rofecoxib	M01AH02	DB00533

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	US	Merck Research Laboratories Massachusetts LLC	19 Aug 2004
Migraine Disorders	US	Merck & Co., Inc.	26 Mar 2004
Acute Pain	US	Merck Research Laboratories Massachusetts LLC	20 May 1999
Osteoarthritis	US	Merck Research Laboratories Massachusetts LLC	20 May 1999
Primary dysmenorrhea	US	Merck Research Laboratories Massachusetts LLC	20 May 1999
Rheumatoid Arthritis	US	Merck Research Laboratories Massachusetts LLC	20 May 1999

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hemophilic arthropathy	Phase 3	US	Tremeau Pharmaceuticals, Inc.Startup	02 Jun 2021
Hemophilic arthropathy	Phase 3	AU	Tremeau Pharmaceuticals, Inc.Startup	02 Jun 2021
Hemophilic arthropathy	Phase 3	CA	Tremeau Pharmaceuticals, Inc.Startup	02 Jun 2021
Hemophilic arthropathy	Phase 3	IT	Tremeau Pharmaceuticals, Inc.Startup	02 Jun 2021
Hemophilic arthropathy	Phase 3	PL	Tremeau Pharmaceuticals, Inc.Startup	02 Jun 2021
Hemophilic arthropathy	Phase 3	ES	Tremeau Pharmaceuticals, Inc.Startup	02 Jun 2021
Hemophilic arthropathy	Phase 3	TR	Tremeau Pharmaceuticals, Inc.Startup	02 Jun 2021
Hemophilic arthropathy	Phase 3	UA	Tremeau Pharmaceuticals, Inc.Startup	02 Jun 2021
Osteoarthritis, Knee	Phase 3	-	Merck Sharp & Dohme Corp.	01 Apr 2003
Pain	Phase 3	FR	Merck Sharp & Dohme Corp.	01 Apr 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00031863 (VICTOR, Pubmed \| J Urol)	Phase 3	Colorectal Cancer Adjuvant	-	Rofecoxib	dfezsyakla(qekkhcpgkg): HR = 0.97 (95% CI, 0.81 - 1.16) View more	Negative	20 Oct 2010
				Placebo
NCT00282386 (APPROVe, Pubmed \| Lancet)	Phase 3	Adenoma \| Colorectal Cancer	2,587	Rofecoxib 25 mg	kqudgfhpgj(enwdgzhztk): hazard ratio = 1.79 (95% CI, 1.17 - 2.73), P-Value = 0.006	Negative	15 Nov 2008
				Placebo
EULAR2008	Not Applicable	Rheumatoid Arthritis	-	Selective COX-2 inhibitor users	poewswuuek(hlcgikucwf) = hrpmwixkvu ekmyhcjoce (urkmakmvob )	-	11 Jun 2008
				Nonselective NSAID users	poewswuuek(hlcgikucwf) = fianmiwxts ekmyhcjoce (urkmakmvob )
VICTOR (ASCO2008)	Phase 3	Colorectal Cancer	-	Rofecoxib 25mg	ktyrsxqfjj(emkdgtltwc): HR = 0.91 (95% CI, 0.78 - 1.07), P-Value = 0.25 View more	Positive	20 May 2008
				Placebo
The VIOXX in prostate cancer prevention study (Pubmed \| Curr Med Res Opin)	Not Applicable	Prostatic Cancer	4,741	Rofecoxib 25 mg	yufmsjjuas(vivbyxncop) = There were no cases of congestive heart failure gojekboqqq (pumqswydty ) View more	Positive	01 Sep 2007
				Placebo
NCT00385606 (GEmcitabine-COxib in NSCLC (GECO), Pubmed \| Lancet Oncol)	Phase 3	Advanced Lung Non-Small Cell Carcinoma First line	400	Gemcitabine 1200 mg/m(2) + Cisplatin 80 mg/m(2)	yzefinxiaa(yxrczykxfc) = avpqtstgsp cytrewwgdk (isjtywjpcp )	Negative	01 Jun 2007
				Gemcitabine 1200 mg/m(2) + Cisplatin 80 mg/m(2) + Rofecoxib 50 mg/day	yzefinxiaa(yxrczykxfc) = timvbaqven cytrewwgdk (isjtywjpcp )
GECO (ASCO2006)	Phase 3	Non-Small Cell Lung Cancer First line	400	Rofecoxib	davrnohops(kbochvgnkh) = updrvvyntn ppzcteslhk (wsuamdbpql ) View more	Negative	20 Jun 2006
EULAR2004	Not Applicable	Juvenile Idiopathic Arthritis	310	Rofecoxib 0.3 mg/kg/day	keyooutxpa(vdwwjgxspz) = Incidence of gastrointestinal disorders was 27, 32, and 40% in LD-Rof, HD-Rof, and NAP groups, respectively; LD-Rof versus NAP was significant uvsvajlsrs (gkqfpxhdqs )	Positive	09 Jun 2004
				Rofecoxib 0.6 mg/kg/day
EULAR2004	Not Applicable	Digestive System Disorders	-	Rofecoxib 50 mg	ofupzlcxnx(rykhyobmmn) = eeukvnagnh tqbtnlbqai (ebvdnescuo ) View more	Positive	09 Jun 2004
				Oxycodone/Paracetamol	ofupzlcxnx(rykhyobmmn) = sbguqnjech tqbtnlbqai (ebvdnescuo ) View more
EULAR2004	Not Applicable	Osteoarthritis	867	Rofecoxib 12.5 mg/d	dlmbnhsatx(mdcgntazqk) = fhtmrbvyuk mjoqledejc (ffdqxxbtlq ) View more	-	09 Jun 2004
				Rofecoxib 25 mg/d	dlmbnhsatx(mdcgntazqk) = uscbtmmrin mjoqledejc (ffdqxxbtlq ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis