GR agonists(Glucocorticoid receptor agonists), cPLA2α agonists(Cytosolic phospholipase A2 agonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Immune System DiseasesRespiratory Diseases

Active Indication

Airway ObstructionAsthmaPulmonary Disease, Chronic Obstructive

Inactive Indication

Bronchitis, ChronicEmphysemaIntermittent asthma

Originator Organization

GSK Plc

Active Organization

Intech Biopharm Ltd.Teva Pharmaceuticals Europe BV

Glaxo Group Ltd.

+ [8]

Inactive Organization

Mylan Pharma UK Ltd.

Drug Highest PhaseApproved

First Approval Date

US (24 Aug 2000),

AsthmaPulmonary Disease, Chronic Obstructive

RegulationOrphan Drug (US)

Structure

Molecular FormulaC36H45NO7

InChIKeyXTZNCVSCVHTPAI-UHFFFAOYSA-N

CAS Registry94749-08-3

View All Structures (2)

261

Clinical Trials associated with Fluticasone propionate/Salmeterol xinafoate

NCT06676319 / RecruitingPhase 2

A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment

This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma.
The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments.
Study details include:
* The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study.
* The investigational treatment duration will be up to approximately 52 weeks.
* The number of visits will be 18.

Start Date07 Nov 2024

Sponsor / Collaborator

Sanofi

NCT06572228 / RecruitingPhase 4

AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma

This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication.
The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA.
The study is also looking at:
• What side effects may happen from taking dupilumab

Start Date26 Aug 2024

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

[+1]

CTR20241130 / CompletedNot Applicable

沙美特罗替卡松吸入粉雾剂在中国成年健康受试者中的一项单中心、随机、开放、空腹单次给药生物等效性试验

[Translation] A single-center, randomized, open-label, fasting single-dose bioequivalence study of salmeterol/fluticasone inhalation powder in healthy Chinese adult subjects

主要研究目的：考察空腹状态下单次经口吸入受试制剂沙美特罗替卡松吸入粉雾剂与参比制剂沙美特罗替卡松吸入粉雾剂在中国健康人体的相对生物利用度，比较两制剂药代动力学特征，评估两制剂的生物等效性。次要研究目的：评价空腹状态下使用受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of the test preparation salmeterol-fluticasone inhalation powder and the reference preparation salmeterol-fluticasone inhalation powder in healthy Chinese subjects after single oral inhalation in the fasting state, to compare the pharmacokinetic characteristics of the two preparations, and to evaluate the bioequivalence of the two preparations. Secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects in the fasting state.

Start Date05 Jun 2024

Sponsor / Collaborator

Aitme (Suzhou) Medical Technology Co., Ltd.

100 Clinical Results associated with Fluticasone propionate/Salmeterol xinafoate

100 Translational Medicine associated with Fluticasone propionate/Salmeterol xinafoate

100 Patents (Medical) associated with Fluticasone propionate/Salmeterol xinafoate

668

Literatures (Medical) associated with Fluticasone propionate/Salmeterol xinafoate

01 Nov 2024·The Journal of Nutrition

Excess Folic Acid Exposure Increases Uracil Misincorporation into DNA in a Tissue-Specific Manner in a Mouse Model of Reduced Methionine Synthase Expression

Article

Author: MacFarlane, Amanda J ; Malysheva, Olga V. ; Brody, Lawrence C. ; Heyden, Katarina E. ; Field, Martha S. ; MacFarlane, Amanda J. ; Brody, Lawrence C ; Malysheva, Olga V ; Field, Martha S ; Heyden, Katarina E

BACKGROUNDFolate and vitamin B12 (B12) are cofactors in folate-mediated 1-carbon metabolism (FOCM), a metabolic network that supports synthesis of nucleotides (including thymidylate [dTMP]) and methionine. FOCM impairments such as a deficiency or imbalance of cofactors can perturb dTMP synthesis, causing uracil misincorporation into DNA.OBJECTIVEThe purpose of this study was to determine how reduced expression of the B12-dependent enzyme methionine synthase (MTR) and excess dietary folic acid interact to affect folate distribution and markers of genome stability in mouse tissues.METHODSHeterozygous Mtr knockout mice (Mtr^+/-) model the FOCM-specific effects of B12 deficiency. Folate accumulation and vitamer distribution, genomic uracil concentrations, and phosphorylated histone H2AX (γH2AX) immunostaining were measured in male Mtr^+/+ and Mtr^+/- mice weaned to either a folate-sufficient control (C) diet (2 mg/kg folic acid) or a high folic acid (HFA) diet (20 mg/kg folic acid) for 7 wk.RESULTSExposure to the HFA diet led to tissue-specific patterns of folate accumulation, with plasma, colon, kidney, and skeletal muscle exhibiting increased folate concentrations compared with control. Liver total folate did not differ. Although unmetabolized folic acid (UMFA) increased 10-fold in mouse plasma with HFA diet, UMFA accounted for <0.2% of total folate in liver and colon tissue. Exposure to HFA diet resulted in a shift in folate distribution in colon tissue with higher 5-methyl-THF and lower formyl-THF than in control mice. Mtr heterozygosity did not impact folate accumulation or distribution in any tissue. Mice on HFA diet exhibited higher uracil in genomic DNA and γH2AX foci in colon. Similar differences were not seen in liver.CONCLUSIONSThis study demonstrates that folic acid, even when consumed at high doses, does not meaningfully accumulate in mouse tissues, although high-dose folic acid shifts folate distribution and increases uracil accumulation in genomic DNA in colon tissue.

01 Oct 2024·Pharmaceutical Research

Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques

Article

Author: Conti, Denise S ; Newman, Bryan ; Mangal, Sharad ; Bielski, Elizabeth ; Shur, Jagdeep ; Farias, Gonçalo ; Conti, Denise S. ; Price, Robert ; Ganley, William J ; Ganley, William J.

AbstractPurposeFor locally-acting dry powder inhalers (DPIs), developing novel analytical tools that are able to evaluate the state of aggregation may provide a better understanding of the impact of material properties and processing parameters on the invivo performance. This study explored the utility of the Morphologically-Directed Raman Spectroscopy (MDRS) and dissolution as orthogonal techniques to assess microstructural equivalence of the aerosolized dose of DPIs collected with an aerosol collection device.MethodsCommercial DPIs containing different strengths of Fluticasone Propionate (FP) and Salmeterol Xinafoate (SX) as monotherapy and combination products were sourced from different regions. These inhalers were compared with aerodynamic particle size distribution (APSD), dissolution, and MDRS studies.ResultsAPSD testing alone might not be able to explain differences reported elsewhere in invivo studies of commercial FP/SX drug products with different Advair® strengths and/or batches. Dissolution studies demonstrated different dissolution rates between Seretide™ 100/50 and Advair® 100/50, whereas Flixotide™ 100 and Flovent® 100 had similar dissolution rates between each other. These differences in dissolution profiles were supported by MDRS results: the dissolution rate is increased if the fraction of FP associated with high soluble components is increased. Principle component analysis was used to identify the agglomerate classes that better discriminate different products.ConclusionsMDRS and dissolution studies of the aerosolized dose of DPIs were successfully used as orthogonal techniques. This study highlights the importance of further assessing invitro tools that are able to provide a bridge between material attributes or process parameters and invivo performance.

01 Sep 2024·New Phytologist

Soil microbial identity explains home-field advantage for litter decomposition

Article

Author: Shigyo, Nobuhiko ; Umeki, Kiyoshi ; Hirao, Toshihide

Unraveling the mechanisms of home-field advantage (HFA) is essential to gain a complete understanding of litter decomposition processes.However, knowledge of the relationships between HFA effects and microbial communities is lacking.To examine HFA effects on litter decomposition, we identified the microbial communities and conducted a reciprocal transplant experiment, including all possible combinations of soil and litter, between sites at two elevations in cool-temperate forests.Soil origin, rather than HFA, was an important factor in controlling litter decomposition processes.Microbiome-wide association analyses identified litter fungi and bacteria specific to the source soil, which completely differed at a low taxonomic level between litter types.The relative abundance of these microbes specific to source soil was pos. correlated with litter mass loss.The results indicated that the unique relationships between plant litter and soil microbes through plant-soil linkages drive litter decomposition processes.In the short term, soil disturbances resulting from land-use changes have the potential to disrupt the effect of soil origin and hinder the advancement of litter decompositionThese findings contribute to an understanding of HFA mechanisms and the impacts of land-use change on decomposition processes in forest ecosystems.

News (Medical) associated with Fluticasone propionate/Salmeterol xinafoate

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

30 Jul 2024

·www.fiercepharma.com

South Korea regulator hits GSK for problems with asthma, acne drugs: report

South Korea’s Ministry of Food and Drug Safety penalized GSK for failing to inform the agency of a change in API specifications in certain asthma meds. South Korea’s Ministry of Food and Drug Safety issued a pair of administrative penalties to GSK for manufacturing and labeling problems on certain asthma and acne treatments, Korea Biomedical Review reports.In its rebuke of GSK, the regulatory agency said the company violated regulations by failing to report changes it made to the APIs used to make Seretide 100 Discus (fluticasone-salmeterol), Seretide 250 Discus, Seretide 500 Discus, and Flixotide Junior Evohaler 50, according to KBR. The drugs are used to treat asthma.The company was also scolded for confusing manufacturing numbers and expiration dates on its labels for acne drug Duacgel 5% (clindamycin phosphate-containing benzoyl peroxide), according to the publication. As part of its action, the agency imposed a 15-day sales suspension from Aug. 1 to 15 on Duacgel 5%, according to KBR.GSK was fined 52.2 million won ($37,680) on Seretide 100 Discus, Seretide 250 Discus, and Seretide 500 Discus. GSK was also hit with a six-month import suspension on Flixotide Junior Evohaler 50mcg that runs from Aug. 1, 2024, to Jan. 31, 2025.Fierce reached out to GSK for comment on the regulatory action.

Drug Approval

08 Aug 2023

·www.drugs.com

Generic, Brand-Name Medication Similarly Effective for COPD

MONDAY, Aug. 7, 2023 -- For patients with chronic obstructive pulmonary disease (COPD), generic and brand-name fluticasone-salmeterol are similarly effective and safe, according to a study published online Aug. 8 in the Annals of Internal Medicine . William B. Feldman, M.D., D.Phil., from Brigham and Women's Hospital in Boston, and colleagues compared the effectiveness and safety of generic (Wixela Inhub) and brand-name (Advair Diskus) fluticasone-salmeterol among patients with COPD in a propensity score-matched cohort study. Of 27,305 Advair Diskus users and 18,064 Wixela Inhub users, 10,012 matched pairs were included in the primary analysis. The researchers found that Wixela Inhub use was associated with a nearly identical incidence of first moderate or severe COPD exacerbation compared with Advair Diskus (hazard ratio, 0.97; 95 percent confidence interval, 0.90 to 1.04) and with a similar incidence of first pneumonia hospitalization (hazard ratio, 0.99; 95 percent confidence interval, 0.86 to 1.15). "In patients with COPD, the generic inhaled corticosteroid-long-acting β-agonist Wixela Inhub had nearly identical effectiveness and safety when compared with brand-name Advair Diskus," the authors write. "Similar studies can provide a useful means of evaluating the clinical effectiveness and safety of complex generic products after approval." Abstract/Full Text (subscription or payment may be required) Posted August 2023

Clinical Result

100 Deals associated with Fluticasone propionate/Salmeterol xinafoate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	R03AK06	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Airway Obstruction	US	Glaxo Group Ltd.	30 Apr 2008
Asthma	US	Glaxo Group Ltd.	24 Aug 2000
Pulmonary Disease, Chronic Obstructive	US	Glaxo Group Ltd.	24 Aug 2000

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	Discovery	EU	Teva Pharmaceuticals Europe BV	18 Aug 2016
Pulmonary Disease, Chronic Obstructive	Discovery	IS	Teva Pharmaceuticals Europe BV	18 Aug 2016
Pulmonary Disease, Chronic Obstructive	Discovery	LI	Teva Pharmaceuticals Europe BV	18 Aug 2016
Pulmonary Disease, Chronic Obstructive	Discovery	NO	Teva Pharmaceuticals Europe BV	18 Aug 2016
Emphysema	Discovery	JP	GSK Plc	28 Jan 2005
Asthma	Discovery	NL	GSK Plc	01 Nov 1999

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04677959 (CONNECT2, CTgov)	Phase 4	Asthma	427	Albuterol+Fluticasone propionate/salmeterol (FS)	skajasznlx(xfafxwymoz) = fvxlzbsubp jahxiyuvhp (bndwpfxpqe, fqbhyxihor - pfmlopgsjy) View more	-	14 Mar 2023
NCT03387852 (CTgov)	Phase 2	Asthma	296	Placebo for dupilumab+Fluticasone+Fluticasone/salmeterol (Placebo)	wqbhcjhukb(cjixycayxn) = bzkjfhgzro rbhbwvbrgy (sqiemdxqqa, zxfnetaiio - vvsdtiomio) View more	-	29 Mar 2022
				Dupilumab+Fluticasone+SAR440340+Fluticasone/salmeterol (SAR440340 + Dupilumab)	wqbhcjhukb(cjixycayxn) = ehwuohjifd rbhbwvbrgy (sqiemdxqqa, ymgjeygfcm - kvdrsvcffc) View more
NCT03219866 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive \| Disease Progression	40	Nebulizers+Pulmicort+Brovana+Atrovent (Nebulizers)	uqolbwjvvl(ymqqkrxpey) = nkvgahwqpw qpeqbzliai (oqwvynnrop, mtulejdpsq - rsdrbkvmse) View more	-	10 Jun 2021
				Dry Powder Inhaler+Spiriva HandiHaler+Advair Diskus (Dry Powder Inhaler)	uqolbwjvvl(ymqqkrxpey) = zalfufswml qpeqbzliai (oqwvynnrop, jgfsxxoact - meysaedwyi) View more
NCT02245672 (Pubmed)	Phase 3	Asthma	1,127	Wixela Inhub	(qtomujhlod) = zgddzfkjty akqkabsubc (fmrtqfruyq ) View more	-	01 Apr 2020
				Advair Diskus	(qtomujhlod) = trtxnqnmfo akqkabsubc (fmrtqfruyq ) View more
NCT02980133 (CTgov)	Phase 3	Persistent asthma	841	Fluticasone Propionate (Fp MDPI 25 mcg BID)	dxedfrexjl(ephuxgamwk) = fogvkiudpx vjtgaaywxe (rxecfujcme, pzrsmrfwgy - gsaxldvyot) View more	-	18 Mar 2020
				Fluticasone Propionate (Fp MDPI 50 mcg BID)	dxedfrexjl(ephuxgamwk) = rvjumymfzc vjtgaaywxe (rxecfujcme, prpyottgka - dbsxjoprez) View more
NCT02251379 (ECATCh, CTgov)	Phase 2	Childhood asthma	155	Home Environmental Intervention+Flovent Diskus+Advair Diskus (ECS + Medication Group)	uakajzimxx(chypdathgc) = uweuklrldz cfoljnzyjp (ooiedfqgkd, icyejxdydu - odwgymypun) View more	-	04 Nov 2019
				Flovent Diskus+Advair Diskus (Medication Group Alone)	uakajzimxx(chypdathgc) = zqpkrxbrfg cfoljnzyjp (ooiedfqgkd, etjvjhferp - gnktzodwai) View more
NCT02061280 (MICT, CTgov)	Phase 4	Asthma	108	fluticasone 100mcg Dry Powder Inhaler+fluticasone/salmeterol 250/50 Dry Powder Inhaler (MICT Trial Design)	mpnadgwtgo(ifgmprrpum) = caggotpkrt wkcbghawup (monkntudvi, knrdcmtxlv - bjbxykggan) View more	-	18 Apr 2018
				fluticasone 100mcg Dry Powder Inhaler+fluticasone/salmeterol 250/50 Dry Powder Inhaler (LASST Trial Design)	mpnadgwtgo(ifgmprrpum) = ihxxiyoiny wkcbghawup (monkntudvi, lrnjxbdzrv - lnphdrkhwl) View more
NCT00355342 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	186	DISKUS inhaler+Salmeterol 50 mcg BID (Salmeterol 50 mcg BID)	xetvlbuprl(devbyzkbdg) = gpxxzzqnlu bvilnaqxne (pghelibzbv, evbncfgmws - wvadiigjtu) View more	-	20 Mar 2018
				DISKUS inhaler+Fluticasone Propionate/Salmeterol 250/50 mcg BID (Fluticasone Propionate/Salmeterol 250/50 mcg BID)	xetvlbuprl(devbyzkbdg) = vmvtidxiey bvilnaqxne (pghelibzbv, xubsbixmvb - vfbixezdee) View more
NCT00363480 (CTgov)	Phase 4	Asthma	221	DISKUS™ powder inhalers+Salbutamol 100 mcg+Salmeterol/Fluticasone 50/250 mcg	pwcfgmqcgu(czwzfmwuqo) = mgigpcsyax egvbtklppa (xxyqvgfjdf, zsetvezfco - cdewppqvkl) View more	-	09 Mar 2018
NCT00455923 (CTgov)	Phase 4	Persistent asthma	100	Seretide (Seretide)	ymofkcdiua(xrpqargjxj) = cqlmfqlrwy vfrsxuraoa (yfcmmkcyzn, ymcbafsfbf - cfoopypbia) View more	-	04 Jan 2018
				Flixotide (Flixotide)	ymofkcdiua(xrpqargjxj) = fhqekiqqwi vfrsxuraoa (yfcmmkcyzn, ofkonilebr - lbuugdfohd) View more

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