Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Nxera Pharma, Zhejiang Hisun, Azurity Pharma - LARVOL DELTA

The effect of lung emptying on the airway deposition of aerosol drugs (ERS 2023) - "Table 1. Relative change of the lung dose as a result of forceful breathe-out in comparison to no breathe-out Drug name Average relative change of lung dose (%) Significance of lung dose change at p=0.05 Onbrez Breezhaler -6.7 significant decrease Relvar Ellipta -1.4 insignificant decrease Seebri Breezhaler -1.1 insignificant decrease Bretaris Genuair 0.3 insignificant increase Foster NEXThaler 3.0 significant increase Bufomix Easyhaler 5.5 significant increase Symbicort Turbuhaler 9.6 significant increase; Respiratory intensive care; Epidemiology; Pulmonary function testing; Cell and molecular biology; General respiratory patient care; Public health"

Critical care

The effect of lung emptying before the inhalation of aerosol drugs on drug deposition in the respiratory system. (PubMed, Int J Pharm X) - "For drugs with negative correlation of lung dose with flow rate (all the studied drugs except the above two) lung emptying caused increased (Foster® by 2.7%), almost unchanged (Seebri®, Relvar®, Bretaris®) and also decreased (Onbrez® by 6.6%) average lung dose...In conclusion, the change of lung dose depends on the degree of lung emptying, but it is also inhaler and drug specific. Forceful exhalation can help in increasing the lung dose only if the above specificities are taken into account."

Journal

"Rhinosporidium seebri" (@nuzhathusain)

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Feb 2024 ➔ May 2025 | Trial primary completion date: Feb 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

"Rhinosporidium seebri .. got the similar slide in my MD exit examination" (@urfe_jan)

Pharmacokinetics, pharmacodynamics, safety and tolerability of glycopyrronium (bromide) in children (6 to less than 12 years) with asthma. Farmacocinética, farmacodinámica, seguridad y tolerabilidad de bromuro de glicopirronio en niños con asma (de 6 a menos de 12 años de edad). (clinicaltrialsregister.eu) - P2 | N=42 | Ongoing | Sponsor: Novartis Farmacéutica, S.A.

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Covis Enters Promotion and Distribution Agreement for Two Respiratory Medicines, Seebri Breezhaler and Ultibro Breezhaler, in Canada (GlobeNewswire) - "Covis Pharma...is pleased to announce that it has entered into an Exclusive Promotion and Distribution Agreement with Novartis Pharmaceuticals Canada Inc. ('Novartis'), whereby Covis has been appointed as Novartis’ exclusive partner to promote and distribute PrSeebri® Breezhaler® and PrUltibro® Breezhaler® in Canada....This agreement for Covis Canada to be the exclusive promotion and distribution partner for Seebri® Breezhaler® and Ultibro® Breezhaler® is effective January 1, 2022 and will continue for an initial term of seven years."

Licensing / partnership • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Failure to update the regulations deprived patients in the countryside of access to medicines? [Google translation] (mgr.farm) - "Pharmaceutical technicians remind that the list of drugs that can be sold in non-pharmacy outlets and pharmacy outlets has not been updated for 10 years....Therefore, they petitioned the Prime Minister for a change in this regard....These substances are found in drugs such as: Nouclaud, Cilostazolum, Cilozek, Ultibro, Breezhaler, Anoro, Solantra, Fluomizin, Spiolto respimat, Cila fleet, Nitroxolin forte, Decilosal, Seebri Breezehaler, Jardiance, Megalia....The new regulation includes, inter alia, modification of the list of active substances that may be present in medicinal products authorized in pharmacy outlets."

Commercial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of Inhaled Glycopyrronium Bromide in COPD: A Randomized, Parallel Group, Dose-Ranging Study (GLIMMER). (PubMed, COPD) - "The incidence of adverse events, both overall and for the most common preferred terms, was low and similar in all treatment groups, including placebo (overall, 22.3-29.3%). Based on the totality of the efficacy and safety data, the optimal GB dose is 25 µg BID."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Muscarinic inhibition of salivary glands with glycopyrronium bromide does not reduce the uptake of PSMA-ligands or radioiodine. (PubMed, EJNMMI Res) - "Muscarinic inhibition of salivation with GPB did not significantly reduce the uptake of PSMA-ligands or radioiodine in salivary glands, and can be dismissed as a potential strategy to reduce toxicity from radionuclide therapies."

Journal • Dental Disorders • Endocrine Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • Xerostomia

Termination of contract for joint promotion and marketing alliance for chronic obstructive pulmonary disease (COPD) [Google translation] (Meiji Seika Press Release) - "Meiji Seika Pharma Co., Ltd....and Novartis Pharma Co., Ltd....have agreed to terminate joint promotion and sales partnership agreements in Japan....With the termination of this agreement, Meiji's promotion for Ultibro and Sieburi will end on March 31, 2021, and Novartis Pharma will continue the promotion on its own from April 1st. Meiji will continue to sell Ultibro and Sieburi for the time being, but Novartis Pharma plans to start shipping the products manufactured and sold by Novartis Pharma from the date of agreement between the two companies within the year as soon as the product distribution environment of the company is ready."

Commercial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Iconovo sets ambitious business goals for 2021 with several important milestones [Google translation] (Dagens industri) - "ICOres® - Iconovo expects to finalize the development project of a budesonide formoterol ICOres product (generic Symbicort®) to Amneal in Q1 so that in Q2 the customer can launch a second pharmacokinetic pilot study....The results of this pilot study are expected in the second half of 2021....ICOcap of generic Novartis products for Ultibro® and Seebri®, Iconovo is expected to deliver the first product to BNC Korea by the end of the year....South Korea is expected to be the first country with a patent expiration at the end of 2023 and thus launch in 2024....Development of ICOpre will be completed during the year...In 2021, all five powder formulations for the development of generic variants for the Ellipta portfolio will be developed...ICOpre will be shown to the public for the first time at the Respiratory Drug Delivery meeting in early May."

Clinical data • Generic launch • New trial • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

[VIRTUAL] A Prospective, Observational Study to Evaluate Effectiveness and Safety of Fixed Dose Combination of Indacaterol Maleate 110 µg + Glycopyrronium Bromide 50 µg (IND/GLY 110/50 µg) in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients. (NAPCON 2020) - No abstract available

Clinical • Observational data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Expanded table: Correct use of inhalers for asthma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Asthma • Immunology • Respiratory Diseases

A 1% glycopyrronium bromide cream for the topical treatment of primary axillary hyperhidrosis: Efficacy and Safety Results from a Phase 3a Randomised Controlled Study. (PubMed, Br J Dermatol) - "1% GPB cream may provide an effective new treatment option exhibiting a good safety profile for patients with primary axillary hyperhidrosis. The long-term open-label part (Phase 3b) is ongoing."

Clinical • Journal • P3 data • Xerostomia

[VIRTUAL] Debate on COPD - II Glycopyrronium bromide versus tiotropium bromide : which to use as a long-acting muscarinic antagonist for the treatment of obstructive airways disease ? Glycopyrronium . (NAPCON 2020) - No abstract available

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

[VIRTUAL] Debate on COPD - II Glycopyrronium bromide versus tiotropium bromide : which to use as a long-acting muscarinic antagonist for the treatment of obstructive airways disease ? Tiotropium. (NAPCON 2020) - No abstract available

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Frequency of Tiotropium Bromide Use and Clinical Features of Patients with Severe Asthma in a Real-Life Setting: Data from the Severe Asthma Network in Italy (SANI) Registry. (PubMed, J Asthma Allergy) - "Among a total of 698 enrolled patients, 35.9% were treated with LAMA (23.3% TBR, 4.5% tiotropium bromide handihaler, 4.5% aclidinium, 3.4% glycopyrronium bromide 0.3% umeclidinium bromide). TBR is still underused in severe asthma in a real-life setting, while a relevant proportion of patients are treated with other LAMA that are not approved for severe asthma treatment. Patients taking LAMA have features characteristic of even more severe asthma."

Clinical • Journal • Asthma • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases

Airway Deposition of Extrafine Inhaled Triple Therapy in Patients with COPD: A Model Approach Based on Functional Respiratory Imaging Computer Simulations. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Two single-inhaler triple therapy (SITT) combinations are currently approved for the maintenance treatment of COPD: extrafine formulation beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB), and non-extrafine formulation fluticasone furoate/vilanterol/umeclidinium (FluF/VI/UMEC). Peripheral (small airways) deposition of all three components (ICS, LABA, and LAMA) was higher from BDP/FF/GB than from FluF/VI/UMEC, based on profiles from patients with moderate to very severe COPD. This is consistent with the extrafine formulation of BDP/FF/GB."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Efficacy and safety of triple combination therapy for treating chronic obstructive pulmonary disease: an expert review. (PubMed, Expert Opin Pharmacother) - "Nowadays, three triple therapies have been approved as fixed-dose combinations (FDCs) for the treatment of COPD: beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FOR/GLY), fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), and budesonide/glycopyrronium bromide/formoterol fumarate (BUD/GLY/FOR)...Since the assessed RCTs were characterized by important confounders, the obtained results should be interpreted with caution. Indeed, FDCs provide advantages in terms of improved adherence to treatment and lower errors in COPD management; however, direct head-to-head comparisons are needed to establish real differences between the currently approved triple FDCs."

Clinical • Combination therapy • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

Predicting Lung Deposition of Extrafine Inhaled Corticosteroid-Containing Fixed Combinations in Patients with Chronic Obstructive Pulmonary Disease Using Functional Respiratory Imaging: An In Silico Study. (PubMed, J Aerosol Med Pulm Drug Deliv) - "FRI was used to evaluate lung deposition of extrafine beclomethasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) and extrafine BDP/FF delivered through pressurized metered dose inhalers and to compare results with reference gamma scintigraphy data...Moreover, the deposition patterns of BDP and FF were similar in both products. Furthermore, the C:P ratios of both products indicated a high peripheral deposition, supporting small airway targeting and delivery of these two extrafine fixed combinations, with a small difference in ratios potentially due to mass median aerodynamic diameters."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

[VIRTUAL] Topical administration of 1% glycopyrronium bromide (GPB) cream is efficient and safe in treatment of primary axillary hyperhidrosis: A randomized placebo-controlled trial (EADV 2020) - No abstract available

Clinical

Drugs for COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Infectious Disease • Tobacco Cessation