[Translation] A randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of arformoterol tartrate nebulized inhalation solution in patients with chronic obstructive pulmonary disease (COPD)

主要目的：评价湖南华纳大药厂股份有限公司生产的酒石酸阿福特罗雾化吸入用溶液在慢性阻塞性肺疾病(COPD)患者中的有效性。次要目的：评价湖南华纳大药厂股份有限公司生产的酒石酸阿福特罗雾化吸入用溶液在慢性阻塞性肺疾病(COPD)患者中的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of arformoterol tartrate nebulized inhalation solution produced by Hunan Huana Pharmaceutical Co., Ltd. in patients with chronic obstructive pulmonary disease (COPD). Secondary objective: To evaluate the safety of arformoterol tartrate nebulized inhalation solution produced by Hunan Huana Pharmaceutical Co., Ltd. in patients with chronic obstructive pulmonary disease (COPD).

Start Date22 May 2024

Sponsor / Collaborator

Hunan Warrant Pharmaceutical Co., Ltd.

CTR20222650 / RecruitingPhase 3

酒石酸阿福特罗吸入溶液治疗成人慢性阻塞性肺疾病的有效性和安全性的多中心、随机、双盲、安慰剂平行对照临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of arformoterol tartrate inhalation solution in the treatment of chronic obstructive pulmonary disease in adults

与安慰剂相比，评价江苏长泰药业有限公司生产的酒石酸阿福特罗吸入溶液治疗慢性阻塞性肺疾病（COPD）的有效性和安全性

[Translation]

To evaluate the efficacy and safety of arformoterol tartrate inhalation solution produced by Jiangsu Changtai Pharmaceutical Co., Ltd. compared with placebo in the treatment of chronic obstructive pulmonary disease (COPD)

Start Date27 Feb 2023

Sponsor / Collaborator

Pharmamax Pharmaceuticals Ltd.

CTR20211924 / CompletedPhase 3

酒石酸阿福特罗雾化吸入用溶液治疗慢性阻塞性肺疾病（COPD）多中心、随机、双盲、安慰剂平行对照的临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical study of arformoterol tartrate nebulized inhalation solution in the treatment of chronic obstructive pulmonary disease (COPD)

以安慰剂作对照，评价酒石酸阿福特罗雾化吸入溶液长期维持治疗慢性阻塞性肺疾病（COPD）的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of arformoterol tartrate nebulized inhalation solution in the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) using placebo as control.

Start Date10 Jan 2022

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Arformoterol Tartrate

100 Translational Medicine associated with Arformoterol Tartrate

100 Patents (Medical) associated with Arformoterol Tartrate

215

Literatures (Medical) associated with Arformoterol Tartrate

31 Dec 2024·COPD: Journal of Chronic Obstructive Pulmonary Disease

Comparative Efficacy of Budesonide/Formoterol Versus Fluticasone/Salmeterol in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis

Review

Author: Shang, Nan ; Liu, Yang ; Jin, Yueping

BACKGROUND/OBJECTIVETo compare the efficacy of budesonide/formoterol (BF) versus fluticasone/salmeterol (FS) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).METHODSThe PubMed, Embase, Cochrane Library, and Web of Science databases were searched for studies comparing BF versus FS in the treatment of COPD from inception to July 17, 2023. Outcomes, including exacerbations, hospitalizations, pneumonia, emergency department (ED) visits for COPD, length of hospitalization, and number of exacerbations, were compared using risk ratio (RR) with corresponding 95% confidence interval (CI) or weighted mean difference (WMD) with 95% CI. All statistical analyses were performed using Stata version 12.0.RESULTSTen studies comprising a total of 136,369 participants were included. Compared with those treated with FS, patients with COPD treated with BF experienced a reduced number of exacerbations (RR 0.91 [95% CI 0.83-1.00]; p = 0.040), hospitalizations (RR 0.77 [95% CI 0.67-0.88]; p < 0.001), and frequency of pneumonia (RR 0.77 [95% CI 0.64-0.92]; p = 0.05). However, no significant difference was observed between BF and FS in terms of ED visits for COPD (RR 0.87 [95% CI 0.69-1.10]; p = 0.243), length of hospitalization (WMD -0.18 [95% CI -0.62-0.27]; p = 0.437), and number of exacerbations (WMD -0.06 [95% CI -0.28-0.16]; p = 0.602). Notably, no significant heterogeneity was noted in length of hospitalization between the two groups, whereas clear heterogeneity was observed in other outcomes (I² > 50%, p < 0.05).CONCLUSIONCompared with FS, BF therapy appears to be a more promising treatment strategy for patients with moderate-to-severe COPD; however, this should be verified in further high-quality studies.

01 Aug 2024·Fundamental & Clinical Pharmacology

The role of β‐adrenergic receptors in the regulation of cardiac tolerance to ischemia/reperfusion. Why do β‐adrenergic receptor agonists and antagonists protect the heart?

Review

Author: Derkachev, Ivan A ; Ryabov, Vyacheslav V ; Tomilova, Eugenia A ; Voronkov, Nikita S ; Sapozhenkova, Ekaterina V ; Singh, Nirmal ; Maslov, Leonid N ; Vyshlov, Evgeny V ; Fu, Feng ; Kolpakov, Viktor V ; Kurbatov, Boris K ; Naryzhnaya, Natalia V ; Pei, Jianming

AbstractBackgroundCatecholamines and β‐adrenergic receptors (β‐ARs) play an important role in the regulation of cardiac tolerance to the impact of ischemia and reperfusion. This systematic review analyzed the molecular mechanisms of the cardioprotective activity of β‐AR ligands.MethodsWe performed an electronic search of topical articles using PubMed databases from 1966 to 2023. We cited original in vitro and in vivo studies and review articles that documented the cardioprotective properties of β‐AR agonists and antagonists.ResultsThe infarct‐reducing effect of β‐AR antagonists did not depend on a decrease in the heart rate. The target for β‐blockers is not only cardiomyocytes but also neutrophils. β1‐blockers (metoprolol, propranolol, timolol) and the selective β2‐AR agonist arformoterol have an infarct‐reducing effect in coronary artery occlusion (CAO) in animals. Antagonists of β1‐ and β2‐АR (metoprolol, propranolol, nadolol, carvedilol, bisoprolol, esmolol) are able to prevent reperfusion cardiac injury. All β‐AR ligands that reduced infarct size are the selective or nonselective β1‐blockers. It was hypothesized that β1‐AR blocking promotes an increase in cardiac tolerance to I/R. The activation of β1‐AR, β2‐AR, and β3‐AR can increase cardiac tolerance to I/R. The cardioprotective effect of β‐AR agonists is mediated via the activation of kinases and reactive oxygen species production.ConclusionsIt is unclear why β‐blockers with the similar receptor selectivity have the infarct‐sparing effect while other β‐blockers with the same selectivity do not affect infarct size. What is the molecular mechanism of the infarct‐reducing effect of β‐blockers in reperfusion? Why did in early studies β‐blockers decrease the mortality rate in patients with acute myocardial infarction (AMI) and without reperfusion and in more recent studies β‐blockers had no effect on the mortality rate in patients with AMI and reperfusion? The creation of more effective β‐AR ligands depends on the answers to these questions.

01 Aug 2024·Journal of Allergy and Clinical Immunology: Global

Effect of fluticasone propionate/formoterol and fluticasone furoate/vilanterol on adolescents with chronic bronchial obstruction

Article

Author: Malmberg, Leo Pekka ; Pelkonen, Anna Susanna ; Tanninen, Tiina Helena ; Mäkelä, Mika Juhani

BackgroundThe combination of an inhaled corticosteroid (ICS) and long-acting β-agonist (LABA) (ICS/LABA) has shown superiority in improving lung function (FEV₁) compared with an ICS alone. The clinical effect of a ICS/LABA combination depends on the fine-particle fraction and the pulmonary deposition.ObjectiveWe sought to compare the efficacy of 2 combinations of an ICS and LABA, namely, fluticasone propionate (FP) and formoterol (FORM) (FP/FORM) and fluticasone furoate (FF) and vilanterol (VI) (FF/VI), in asthmatic adolescents with chronic bronchial obstruction.MethodsFP/FORM (125 μg/5 μg, 2 doses twice daily via the k-haler [Mundipharma, Cambridge, UK]) and FF/VI (92 μg/22 μg, once daily via the Ellipta inhaler [GlaxoSmithKline]) were administered to adolescents aged 12 to 17 years who required regular antiasthmatic medication and had a ratio of FEV₁ to forced vital capacity (FEV₁/FVC) less than -1.65 SD in a 2-sequence, 16-week crossover trial. The primary efficacy end point was change in FEV₁ compared with baseline. Secondary end points were FEV₁/FVC ratio, maximal expiratory flow at 50% of the FVC, impulse oscillometry indices respiratory resistance at 5 Hz (R5), difference between R5 and respiratory resistance at 20 Hz (R20), area of reactance, and Asthma Control Test score.ResultsBoth ICS/LABA combinations resulted in a significant improvement in FEV₁ and maximal expiratory flow at 50% of the FVC z scores without any significant difference between FP/FORM and FF/VI, with 40% of patients with either treatment achieving a normal prebronchodilator FEV₁/FVC z score. Neither area of reactance nor difference between R5 and R20 improved significantly with either treatment.ConclusionBoth ICS/LABA combinations demonstrated significant improvements in FEV₁z score. More than one-third of the asthmatic adolescents with prolonged bronchial obstruction achieved a normal prebronchodilator FEV₁/FVC ratio.

News (Medical) associated with Arformoterol Tartrate

12 Nov 2024

·www.prnewswire.com

Sanofi/Regeneron Pharmaceuticals' DUPIXENT Approval Marks a Significant Shift in Chronic Obstructive Pulmonary Disease Treatment Landscape | DelveInsight

After over a decade without notable progress in treating chronic obstructive pulmonary disease, patients with this ongoing condition now have two new treatment options, with more expected in the future. Regeneron and Sanofi recently revealed that the FDA has expanded the approved uses of their widely successful drug DUPIXENT to include COPD treatment. This marks the drug's sixth approved indication in the US, following its first approval seven years ago for atopic dermatitis. LAS VEGAS, Nov. 12, 2024 /PRNewswire/ -- Chronic obstructive pulmonary disease (COPD) is a progressive lung condition characterized by obstructed airflow, making breathing difficult. It primarily encompasses two main conditions: chronic bronchitis and emphysema, often coexisting. COPD typically develops due to long-term exposure to irritants such as cigarette smoke, air pollution, or occupational dust. As per DelveInsight analysis, the diagnosed prevalent population of COPD in the 7MM was around 44 million in 2023. These cases of COPD in the 7MM are expected to increase at a significant CAGR of 1.4% throughout the study period (2020–2034). As per the estimates, the majority of cases of COPD are in females as compared to males, in the US. But in EU4 and the UK, and Japan the diagnosed cases of males represent the majority of the cases. Overall, in the 7MM, females are predominantly high in number. In 2023, the US had around 3 million, 9 million, 5 million, and 1 million cases of GOLD 1, GOLD 2, GOLD 3, and GOLD 4, respectively based on the severity of airflow limitation. Estimates suggest that airflow limitation was higher in GOLD 2 severity. Various types of medications are used to manage COPD symptoms and complications, including bronchodilators, which help relax the muscles around the airways. This relaxation opens the airways and makes breathing easier. Most bronchodilators are administered via an inhaler. In more severe cases, the inhaler may also contain steroids to reduce inflammation. Some commonly used short-acting and long-acting bronchodilators for COPD management include Albuterol (ProAir HFA, Ventolin HFA, and others), Ipratropium (Atrovent HFA), Levalbuterol (Xopenex), Aclidinium (Tudorza Pressair), Arformoterol (Brovana), and Formoterol (Perforomist). In the LABA category, medications such as Striverdi Respimat, Arcapta/Onbrez, Serevent, and Brovana are included, while the LAMA class features drugs like Spiriva (available as Spiriva HandiHaler and Spiriva Respimat), Tudorza Pressair, Incruse Ellipta, Yupelri, Seebri Neohaler, and Lonhala Magnair. Since the generic version of Brovana was approved in April 2020, its market share has declined. Additionally, Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler were discontinued in the US in March 2020, which means they no longer contribute to market size. Patients who do not respond to single therapies are often prescribed double or triple therapy. Among the double therapies, the LABA+ICS combination is widely recommended, with drugs such as Symbicort, Breo Ellipta, and Advair. There are also LABA+LAMA combinations, including Anoro Ellipta, Stiolto Respimat, and Bevespi Aerosphere. In July 2020, the US FDA approved AstraZeneca's BREZTRI AEROSPHERE for the maintenance treatment of patients with COPD. Additionally, in October 2020, TRIXEO AEROSPHERE (a combination of formoterol fumarate, glycopyrronium bromide, and budesonide) received marketing authorization in the EU for the maintenance treatment of adult patients with moderate to severe COPD who are not adequately controlled by either a combination of an ICS and LABA or a LABA and LAMA. Currently, two triple combination therapies are available in the US: BREZTRI and TRELEGY ELLIPTA. Learn more about the FDA-approved COPD drugs @ Drugs for COPD Treatment Recently, Sanofi/Regeneron Pharmaceuticals' DUPIXENT added one more jewel to its crown by getting a label expansion nod for COPD from the FDA, EU, and NMPA. DUPIXENT's approval as the first targeted therapy for COPD represents a significant advancement in the treatment landscape for the disease. Unlike conventional treatments, which largely aim to manage symptoms, DUPIXENT specifically targets the IL-4 and IL-13 pathways linked to type 2 inflammation, a key driver in a subset of COPD patients. This precision in targeting allows for a more tailored treatment, especially for patients with elevated eosinophils, who often experience more frequent exacerbations and worse outcomes. The Phase III BOREAS trial demonstrated that patients treated with DUPIXENT experienced a 30% reduction in moderate-to-severe exacerbations over 52 weeks, significant improvements in lung function, and enhanced quality of life. By Week 52, those on DUPIXENT had improved prebronchodilator FEV1 by 160 mL compared to 77 mL in the placebo group. DUPIXENT was also well-tolerated, with a low frequency of adverse events. These results suggest that DUPIXENT could drastically shift COPD management by reducing exacerbations, improving lung function, and offering a safer, targeted therapy for patients with type 2 inflammation. To know more about COPD treatment options, visit @ New Treatment for COPD The chronic obstructive pulmonary disease pipeline possesses potential drugs in mid-stage developments to be launched in the near future. Itepekimab (Sanofi/Regeneron Pharmaceuticals), Benralizumab (AstraZeneca), Tezepelumab (Amgen/AstraZeneca), Mepolizumab (GSK), and others shall further create a positive impact on the market. Discover which therapies are expected to grab major COPD market share @ COPD Market Report Itepekimab is a fully human monoclonal antibody that targets interleukin-33 (IL-33), a protein involved in both type 1 and type 2 inflammation. The drug is administered via subcutaneous injection. Preclinical studies demonstrated that REGN3500 effectively inhibited several markers of both inflammatory types. Regeneron and Sanofi are investigating REGN3500 in diseases related to respiratory and dermatological inflammation. Currently, REGN3500 is in a Phase III clinical trial for COPD and was developed using Regeneron's VelocImmune technology, which produces optimized fully human antibodies. The development is part of a global collaboration between Regeneron and Sanofi. FASENRA (benralizumab) is a humanized recombinant monoclonal antibody of the IgG1k immunoglobulin type that selectively targets the alpha chain of the interleukin 5 receptor (IL-5R) found on eosinophils and basophils. It prevents IL-5 from binding and stops the hetero-oligomerization of the IL-5R's alpha and beta subunits, thereby inhibiting signal transduction. Additionally, it is an afucosylated IgG, which enhances its affinity for the FcγRIIIα receptor on natural killer cells, macrophages, and neutrophils. Approved by the FDA in November 2017 for severe eosinophilic asthma, benralizumab was developed by MedImmune, AstraZeneca's global biologics R&D division. The company is currently conducting Phase III clinical trials for FASENRA as a treatment for COPD. TEZSPIRE (tezepelumab), a pioneering human monoclonal antibody created by Amgen and AstraZeneca, has shown considerable therapeutic potential for various respiratory conditions. Originally intended for treating COPD, TEZSPIRE has yielded encouraging results in decreasing moderate-to-severe exacerbations in patients with high blood eosinophil counts. Recent findings from the Phase IIa COURSE Trial, unveiled at the ATS 2024 conference, underscored TEZSPIRE's effectiveness in minimizing COPD exacerbations among patients with different eosinophil levels. Mepolizumab is currently undergoing Phase III clinical trials for COPD, particularly in patients with frequent exacerbations and elevated eosinophil levels. It is available as an injectable solution and a powder for reconstitution for subcutaneous administration. The IL-5 receptor complex activates several signaling pathways that lead to the release of cytokines, neuromediators, chemokines, and various kinases, which facilitate eosinophil differentiation, proliferation, recruitment, and degranulation. Mepolizumab works by inhibiting the formation of the IL-5 receptor complex, thereby preventing eosinophil activation. This disruption affects normal eosinophil maturation and function, leading to decreased eosinophilic airway inflammation and reduced eosinophil survival. Discover more about drugs for COPD in development @ COPD Clinical Trials The anticipated launch of these emerging therapies for COPD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the COPD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for COPD in the 7MM is expected to grow from USD 16 billion in 2023 with a significant CAGR of 5% by 2034. This growth is mainly driven by the rise in the number of prevalent cases of COPD, ongoing clinical research, and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Chronic Obstructive Pulmonary Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the COPD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The COPD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of COPD Subtype-specific Diagnosed Prevalent Cases of COPD Gender-specific Diagnosed Prevalent Cases of COPD Age-specific Diagnosed Prevalent Cases of COPD Diagnosed Prevalent Cases of COPD Based on Severity of Airflow Limitation Diagnosed Prevalent Cases of COPD Based on Symptoms and Exacerbation History The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM COPD market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this COPD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the COPD market. Also, stay abreast of the mitigating factors to improve your market position in the COPD therapeutic space. Related Reports Chronic Obstructive Pulmonary Disease Pipeline Chronic Obstructive Pulmonary Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COPD companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma plc, Immunotek, Yungjin Pharm. Co., Ltd., Pulmotect, Inc., Tetherex Pharmaceutical, CSL Behring, AstraZeneca, Novartis, Genentech, Vertex Pharmaceuticals, EmeraMed, Afimmune, Mereo BioPharma, Synairgen, Adamis Pharmaceuticals, Quercegen Pharmaceuticals LLC, Regend Therapeutics, Meridigen Biotech Co., Ltd., Pulmatrix, Eisai, GlaxoSmithKline, EpiEndo Pharmaceuticals, 3SBio, OmniSpirant, Foresee Pharmaceuticals, Amgen, Organicell Regenerative Medicine, Arrowhead Pharmaceuticals, ProterixBio, RS BioTherapeutics, MitoRx, C4X Discovery, Respiratorius, ARK biosciences, Incannex, GNI Pharma, Celon pharma, Alveolus Bio, Kinaset therapeutics, Landos Biopharma, Parion Sciences, KeyMed Biosciences, Bioneer corporation, AlgiPharma, Palobiofarma, Dimerix Bioscience, Glenmark Pharmaceuticals, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. About DelveInsight DelveInsight is a leading 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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3Phase 2

09 Sep 2022

·endpts.com

Brand name inhalers are very good at blocking competition, better even than nebulizers, study finds

While just three brand-name inhalers approved between 1986 and 2020 now face generic competition (thanks in a large part to patent thickets and companies shifting old active ingredients to new devices), the same sort of long monopoly extensions are not as prevalent for nebulizers, a new study published today in Nature Biotechnology explains. The Harvard and University of Calgary authors note that nearly one-third of brand-name nebulizer solutions, which include drugs for asthma or other conditions in an aerosol mist form, faced generic competition before expiration of FDA-listed patents, compared to just 2% of brand-name inhalers. What’s more is that when considering actual market exclusivity (i.e., “the time from brand-name drug approval to generic competition, brand-name drug discontinuation, or 31 December 2020, whichever occurred first”), 13 brand-name solutions for nebulization had a median of just 5.2 years (IQR: 3.5–10.4 years) without generic competition. In contrast, inhalers saw 17.4 years of median protection when counting hops to new devices as a single product line (IQR: 13.2–23.2 years). Brand-name inhalers making such shifts to new devices, they wrote, as to a means to obtaining a longer period of exclusivity include Merck’s Proventil and Foradil, GSK’s Ventolin, Boehringer Ingelheim’s Combivent and Atrovent, and AstraZeneca’s Pulmicort. So why the wide discrepancy between inhalers and nebulizers? First author William Feldman of Harvard Medical School told Endpoints News via email: But nebulizers also saw shorter periods of market exclusivity because of delays in the release of brand-name nebulizer solutions, Feldman , Doni Bloomfield, Reed Beall and Aaron Kesselheim wrote. “The time between the release of inhalers and the release of the same ingredients in nebulized form has meant that certain at-risk patients lacked access to preferred forms of treatment,” they wrote. “Physicians frequently rely on nebulizers to treat asthma and COPD, because some patients may not be able to use inhalers and because some simply favor nebulizers. A recent study of Black and Latino/Latina patients with moderate-to-severe asthma, for example, found that 67% chose to use nebulizers for SABA administration.” Another concerning finding cited by the authors is a recent turn by brand name manufacturers to enantiomers of older racemic formulations — levalbuterol (an enantiomer of racemic albuterol) and arformoterol (an enantiomer of racemic formoterol) — “despite little, if any, clinical benefit associated with the newer products compared to the older ones,” they added. So how to fix this situation? The authors point to regulatory reforms, saying it’s:

26 Aug 2022

·www.biospace.com

FDA Review: Incyte, Pfizer, Iovance and More

Sarah Silbiger/Getty Images The FDA is keeping busy as summer winds down, with approvals, Orphan Drug Designations and other actions. Here’s what the agency has been up to this week. August 26 Incyte announced that the FDA has approved Pemazyre (pemigatinib) for the treatment of relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangements. The drug is a selective FGFR inhibitor. The approval marks the first and only targeted treatment for this indication, Incyte stated. It is also the second approval for Pemazyre, which already has FDA authorization for adults previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement. Inhibikase Therapeutics received the go-ahead from the FDA to launch a study of IkT-001Pro for chronic myelogenous leukemia. IkT-001Pro is a prodrug formulation of imatinib mesylate and is designed to improve the safety of Gleevec (imatinib). Suzhou Junjing Biomedical Technology Co.’s IND for JS110 was approved by the FDA. The drug is a small molecule inhibitor of the nuclear export protein XPO1 for advanced tumors. August 25 Iovance Biotherapeutics initiated a rolling BLA submission to the FDA for li a tumor infiltrating lymphocyte therapy, in advanced melanoma patients. The therapy is intended for patients who have progressed on or after previous anti-PD-1/L1 therapy, are BRAF mutation positive and have previously received BRAF or BRAF/MEK inhibitor therapy. Century Therapeutics received the green light from the FDA to proceed with its ELiPSE-1 trial of CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is an allogeneic cell therapy engineered with four complementary functionalities, including a CD19 CAR for tumor targeting, IL-15 support for enhanced persistence, Allo-Evasion technology to prevent host rejection and enhanced persistence. It also has a safety switch to eliminate the drug if necessary. Therapeutic Solutions International filed an amendment with the FDA regarding its currently open Phase III trial. The company is requesting that eligibility be expanded to include all patients suffering from acute respiratory distress syndrome (ARDS) regardless of cause. It is currently only recruiting patients with advanced ARDS caused by COVID-19. B.More reported the FDA approved its IND application to launch a Phase IIb trial of SYNP-101 (psilocybin) for patients with alcohol use disorder. The trial is expected to start in early 2023. August 24 Calyptus Pharmaceuticals’s Abbreviated NDA (ANDA) for Brovana (arformoterol tartrate inhalation solution) was approved by the FDA. The drug, co-developed with VistaPharm, is indicated for the long-term, twice-daily maintenance treatment of bronchoconstriction in COPD patients, including chronic bronchitis and emphysema. Surgalign Holdings reported FDA 510(k) clearance of the Cortera Spinal Fixation System. It will integrate the system with the HOLO Portal surgical guidance system. Tachyon Therapeutics received the go-ahead from the FDA to initiate a Phase Ia trial of TACH101 for advanced solid tumors. The drug is a KDM4 inhibitor. Ainos submitted an IND to the FDA for a Phase II trial of Veldona, a low-dose oral interferon-alpha formulation, for mild symptoms related to COVID-19. August 23 Foghorn Therapeutics announced that the FDA placed a full clinical hold on a Phase I dose escalation study of FHD-286 in relapsed or refractory acute myelogenous leukemia and myelodysplastic syndrome. The drug is a BRG1/BRM inhibitor. The hold was based on a death in the study, but it has not been determined if it is related to the therapy or the disease. Jaguar Health reported the FDA has accepted its application for review for Orphan Drug Designation for Crofelemer. The drug is being evaluated for a rare congenital diarrheal disorder, microvillus inclusion disease (MVID). K36 Therapeutics received the green light from the FDA to run a Phase I trial of KTX-1001 in patients with relapsed and refractory multiple myeloma, enriching for patients with the t(4;14) genetic translocation. KTX-1001 is a small molecule methyltransferase inhibitor of the multiple myeloma SET domain known as MMSET. Abbott Laboratories’ Proclaim Plus spinal cord stimulation system featuring FlexBurst360 therapy was approved by the FDA. The product offers pain coverage across up to six areas of the trunk and/or limbs. Synlogic reported the FDA granted Fast Track designation to its SYNB1353 for the treatment of homocystinuria. iECURE announced the FDA has granted Rare Pediatric Disease Designation to GTP-506. The drug is being developed to treat Ornithine Transcarbamylase (OTC) deficiency. August 22 Pfizer was instructed by the FDA to run a clinical trial to evaluate an additional course of its antiviral combination therapy Paxlovid in people who experienced COVID-19 rebound infections. The company is expected to have initial data by Sept. 30, 2023. Pharvaris reported the FDA has placed a clinical hold on the trials of PHA121 under two Pharvaris INDs for treatment of hereditary angioedema (HAE). The hold is based on reviews of nonclinical data. Ocelot Bio’s OCE-205 received Orphan Drug Designation from the FDA for treatment of hepatorenal syndrome. It is currently enrolling patients in a Phase II trial of the drug in hepatorenal syndrome with acute kidney injury. Thermedical received the green light from the FDA to run a trial for SERF ablation to treat ventricular tachycardia patients resistant to conventional treatment. SERF ablation with the Durablate catheter will be the focus of the study. DynamiCure was cleared by the FDA to run a Phase I trial of DC-6001, a therapeutic antibody against CD93, in adults with a range of advanced cancers. Insulet received clearance of its Omnipod 5 Automated Insulin Delivery System for children aged two years and older with Type 1 diabetes. Minerva Neurosciences submitted a New Drug Application to the FDA for roluperidone for negative symptoms in patients with schizophrenia.

AntibodyOrphan DrugCell TherapySmall molecular drugFast Track

100 Deals associated with Arformoterol Tartrate

External Link

KEGG	Wiki	ATC	Drug Bank
D02981	Arformoterol Tartrate	R03	DB01274

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bronchitis, Chronic	US	Lupin, Inc.	06 Oct 2006
Pulmonary Emphysema	US	Lupin, Inc.	06 Oct 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tracheal Stenosis	Phase 3	CN	Hunan Warrant Pharmaceutical Co., Ltd.	22 May 2024
Pulmonary Disease, Chronic Obstructive	Phase 3	CN	Pharmamax Pharmaceuticals Ltd.	27 Feb 2023
Asthmatic bronchitis	Phase 1	CN	Guangdong Yili Jituan Pharmaceutical Co. Ltd.	22 Jan 2021
Chronic tracheitis	Phase 1	CN	Guangdong Yili Jituan Pharmaceutical Co. Ltd.	22 Jan 2021
Dyspnea	Phase 1	CN	Guangdong Yili Jituan Pharmaceutical Co. Ltd.	22 Jan 2021
Bronchitis, Chronic	Preclinical	US	Sumitomo Pharma America, Inc.	01 Apr 2002
Pulmonary Emphysema	Preclinical	US	Sumitomo Pharma America, Inc.	01 Apr 2002
Asthma	Discovery	US	Sumitomo Pharma America, Inc.	01 Jan 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03219866 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive \| Disease Progression	40	Nebulizers+Pulmicort+Brovana+Atrovent (Nebulizers)	wioasonjhy(ircdkjgmgc) = zmpgawsjjt nzarjxlvxv (sbhdxozmwz, perednvxwn - qpkudaurgn) View more	-	10 Jun 2021
				Dry Powder Inhaler+Spiriva HandiHaler+Advair Diskus (Dry Powder Inhaler)	wioasonjhy(ircdkjgmgc) = dfzuzxlbtf nzarjxlvxv (sbhdxozmwz, aayjgcfsha - lthlpayoih) View more
NCT02275481 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	66	Arformoterol tartrate inhalation solution (BROVANA)	zutyyvuqdi(yfywhilnjy) = ayxetwoiza djumlhhxmq (hfwzqbwykg, eulirbnhoj - jwccdrtfde) View more	-	02 Oct 2017
				Tiotropium (SPIRIVA)	zutyyvuqdi(yfywhilnjy) = dvwrreedhk djumlhhxmq (hfwzqbwykg, ktyotpxspq - dcrrpdotvm) View more
NCT00909779 (Pubmed \| Chest) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	841	arformoterol tartrate	(cbzngverqt) = qfktckmhxt txcchhvgor (nrcngxdaky ) View more	Positive	01 Dec 2014
				Placebo	(cbzngverqt) = namdwyhaaq txcchhvgor (nrcngxdaky ) View more
NCT01391559 (CTgov)	Not Applicable	Pulmonary Disease, Chronic Obstructive	20	Arformoterol (Arformoterol)	iwvxlrgunj(gvuakyqekn) = qrczoubqdy pujhypylqg (tzmvlgyraz, nhhhrnubdb - furhwigxsv) View more	-	07 Aug 2013
				salmeterol (Salmeterol)	iwvxlrgunj(gvuakyqekn) = ganmocxpfc pujhypylqg (tzmvlgyraz, rtxikwyfmi - mfdcsdxovb) View more
NCT00846287 (CTgov)	Not Applicable	Pulmonary Disease, Chronic Obstructive	16	Hyperpolarized Helium-3 (Saline)	msemsuqelr(jmurrnxsqz) = fbkuiydbyz vkdytubfxj (bemfpohoib, ehbwrbbwde - hjmrbyawei) View more	-	01 Nov 2012
				Hyperpolarized Helium-3+Aformoterol (Drug Subjects)	msemsuqelr(jmurrnxsqz) = lsrswsmegn vkdytubfxj (bemfpohoib, jjgzptzqhf - bgizswktnr) View more
NCT00424528 (CTgov)	Phase 4	Pulmonary Emphysema \| Bronchitis	235	Placebo+Arformoterol Tartrate Inhalation Solution (Arformoterol 15 Mcg Twice Daily)	rgafavngjw(hrpgvmdyiu) = ejyymihoci xczsncyxwh (bfhghvgjns, ondcspirxe - ebhmyhnlps) View more	-	02 Apr 2009
				Placebo+Tiotropium (Tiotropium 18 Mcg Once Daily)	rgafavngjw(hrpgvmdyiu) = eogmdbizhc xczsncyxwh (bfhghvgjns, wbviugejbx - atvexmhloa) View more
NCT00424528 (Pubmed \| Respir Med)	Phase 4	Pulmonary Disease, Chronic Obstructive	235	Arformoterol 15microg BID	(zgbvqfrsta) = lnxstnqwaa gfilmvkmmp (sktqwphzpw )	-	01 Apr 2009
				Tiotropium 18microg QD	(zgbvqfrsta) = uitxicmtgl gfilmvkmmp (sktqwphzpw )

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