arformoterol / Generic mfg. - LARVOL DELTA

Nebulized Long-Acting Bronchodilators to Treat Acute Respiratory Failure in an Older Adult: A Case Report. (PubMed, Cureus) - "This report describes the case of a 79-year-old man admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure due to coronavirus disease 2019 (COVID-19) and treated with long-acting nebulized bronchodilators, arformoterol and revefenacin. In this case, both medications were used for their rapid-onset and long-duration bronchodilator activity to treat acute respiratory failure secondary to COVID-19. This older adult clinically improved within three days of nebulized long-acting bronchodilator use."

Journal • Acute Respiratory Distress Syndrome • Chronic Obstructive Pulmonary Disease • Critical care • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Formulation and evaluation of carrier-based dry powders containing budesonide and arformoterol for inhalation therapy. (PubMed, Pharm Dev Technol) - "(p-value for AUC0-t and Cmax: 0.646 and 0.153, respectively) The key findings highlight that formulation optimization significantly reduces particle aggregation and improves drug delivery efficiency in DPI (FPF for AFT and BUD: 39.4% and 50.6%, respectively), suggesting the potential for enhanced clinical outcomes in asthma and COPD patients. This study provides valuable insights for the formulation development of inhalable therapies."

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

Comparison table: Inhaled drugs for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

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

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

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tobacco Cessation

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? (PubMed, Fundam Clin Pharmacol) - "It 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."

Journal • Review • Cardiovascular • Myocardial Infarction • Reperfusion Injury

Unveiling Arformoterol as a potent LSD1 inhibitor for breast cancer treatment: A comprehensive study integrating 3D-QSAR pharmacophore modeling, molecular docking, molecular dynamics simulations and in vitro assays. (PubMed, Int J Biol Macromol) - "In contrast, the IC values obtained for the control (tranylcypromine) in exposure to MCF-7 and MDA-MB-231 cells were 104.6 ± 1.69 μM and 77 ± 0.67 μM, respectively. Arformoterol enhanced apoptosis and induced cell cycle arrest at the G2/M phase, both in MCF-7 and MDA-MB-231 cancer cells. Based on our findings, we propose that Arformoterol represents a promising candidate for breast cancer treatment, owing to its potent LSD1 inhibitory activity."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor • S100A8

Determination of 14 β-agonists in animal meat by ultra high performance liquid chromatography-tandem mass spectrometry (PubMed, Se Pu) - "In this study, a method based on ultra high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) was established for the rapid detection of 14 β-agonists (clenbuterol, salbutamol, ractopamine, clorprenaline, terbutaline, tulobuterol, bromobuterol, bambuterol, zilpaterol, mabuterol, fenoterol, arformoterol, cimaterol, and cimbuterol) in animal food sources. The results were close to those of the national standard method, indicating that the method is accurate and reliable. Moreover, the proposed method has good stability and high accuracy; thus, it is suitable for the qualitative and quantitative determination of β-agonists in animal meat."

Journal • Cardiovascular • Movement Disorders

Leukotriene Inhibitors Effect on Post-Traumatic Osteoarthritis: A Real-World Evidence Comparative Effectiveness Study (ACR Convergence 2023) - "Additionally, subjects had to be users of leukotriene inhibitors (montelukast, zafirlukast, or zileuton) or an active comparator that consisted of long-acting beta agonists (albuterol, arformoterol, formoterol, indacaterol, olodaterol, salmeterol, terbutaline, or vilanterol) for any duration from the index date up to 6 months after. Users of leukotriene inhibitors undergoing ACL or meniscal surgery may have lower odds of post-traumatic OA compared with users of long-acting beta agonists."

Clinical • HEOR • Real-world • Real-world evidence • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology

Evaluation of a New Formulary Medication Via Vibrating Mesh Nebulizer (AARC 2023) - "The medications used were NACL 0.9% BID, Budesonide .5mg BID, Arformoterol Tartrate 15 µg BID, and Revefenacin 175 µg QDAY. Visual inspection, temperature, and time were adequate throughout the study. Therefore, we believe Revefenacin can be adequately delivered through the vibrating mesh nebulizer. View this table:View inlineView popupTable 1."

Chronic Obstructive Pulmonary Disease

Lungs on Lockdown - Three Children Requiring Extracorporeal Life Support for Status Asthmaticus After Pandemic-related Social Distancing (ATS 2023) - "Finally, we describe a 3-year-old, ex-26 week male with BPD on 1 L/min O2 during sleep at baseline, and reported asthma on budesonide and arformoterol with multiple prior hospitalizations for respiratory exacerbations...Finally, we describe a 3-year-old, ex-26 week male with BPD on 1 L/min O2 during sleep at baseline, and reported asthma on budesonide and arformoterol with multiple prior hospitalizations for respiratory exacerbations...CT chest imaging and flexible bronchoscopy with bronchoalveolar lavage failed to reveal other obvious comorbidities. We hypothesize that they were uniquely vulnerable, especially to common seasonal respiratory viruses, as COVID-19-related social-distancing was relaxed."

Clinical • Asthma • Atopic Dermatitis • Bronchopulmonary Dysplasia • Dermatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Obstructive Sleep Apnea • Pediatrics • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Sleep Disorder

Merging enzymatic and synthetic chemistry with computational synthesis planning. (PubMed, Nat Commun) - "This approach extends the space of retrosynthetic moves by thousands of uniquely enzymatic one-step transformations, discovers routes to molecules for which synthetic or enzymatic searches find none, and designs shorter routes for others. Application to (-)-Δ tetrahydrocannabinol (THC) (dronabinol) and R,R-formoterol (arformoterol) illustrates how our strategy facilitates the replacement of metal catalysis, high step counts, or costly enantiomeric resolution with more elegant hybrid proposals."

Journal

Current pharmacogenomic recommendations in chronic respiratory diseases: Is there a biomarker ready for clinical implementation? (PubMed, Expert Rev Respir Med) - "The main pharmacogenomics recommendation in this field is to assess CFTR variants for using ivacaftor and its combination. The drugs' labels for arformoterol, indacaterol, and umeclidinium indicate a lack of influence of genetic variants in the pharmacokinetics of these drugs...In addition, there are reports of potential pharmacogenetic variants in the treatment with acetylcysteine (TOLLIP rs3750920) and captopril (ACE rs1799752). The genetic variations for warfarin also are presented in PharmGKB and CPIC for patients with pulmonary hypertension. The pharmacogenomics recommendations for lung diseases are limited. The clinical implementation of pharmacogenomics in treating respiratory diseases will contribute to the quality of life of patients with chronic respiratory diseases."

Biomarker • Journal • Cardiovascular • Hypertension • Infectious Disease • Oncology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CYP2C19

Lupin Signs Agreement to Acquire Two Inhalation Brands from Sunovion (Lupin Pharmaceuticals Press Release) - "Global pharmaceutical major Lupin Limited (Lupin) today announced signing of an agreement to acquire all rights to two inhalation medicines, Brovana® (arformoterol tartrate) Inhalation Solution and Xopenex HFA® (levalbuterol tartrate) Inhalation Aerosol, from Sunovion Pharmaceuticals Inc. (Sunovion) for a purchase price of $75 million. Lupin expects the transaction to be accretive to earnings in the first year."

M&A • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Calyptus Pharmaceuticals Announces Approval of Arformoterol Tartrate Inhalation Solution, EQ 0.015 mg Base/2 ml (PRNewswire) - "Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ('FDA') granted approval to an Abbreviated New Drug Application (ANDA) for a generic version of Brovana...Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema."

ANDA • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Merging biocatalysis and synthetic chemistry with chemoenzymatic synthesis planning (ACS-Fall 2022) - "We benchmark the hybrid search strategy against purely enzymatic and purely conventional organic searches to demonstrate that it explores a different space of potential routes, leading to the identification of novel and promising synthesis plans that could not be found without combining enzymatic and organic reactions. We explore how our algorithm can be applied to the discovery of new chemoenzymatic synthesis plans, using the syntheses of dronabinol and arformoterol as case studies."

Alembic Pharmaceuticals receives USFDA final approvl for Arformoterol Tartrate Inhalation Solution (Equitybulls) - "Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 ml Unit-dose Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RlD), Brovana Inhalation Solution, 15 mcg/2 ml, of Sunovion Pharmaceuticals Inc. Arformoterol Tartarate Inhalation Solution is a longacting beta2-adrenergic agonist (beta2-agonist) indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema."

ANDA • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Lupin Receives Approval from U.S. FDA for Arformoterol Tartrate Inhalation Solution15 mcg (base)/2 ml (Lupin Pharmaceuticals Press Release) - "Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml, Unit-dose Vialsto market a generic equivalent of Brovana®Inhalation Solution, 15 mcg/2 ml of Sunovion Pharmaceuticals Inc. (Sunovion)...for the long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD)."

ANDA • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

FDA approves 3 generic drugs including Teva COPD treatment [Google translation] (Health Korea News) - “The US Food and Drug Administration (FDA) approved the application for drug approval (ADND) for three generic drugs on the 9th (local time). According to the FDA, Teva Pharmaceutical has been approved as a prescription drug for Arformoterol Tartrate 0.015 mg, an inhalation solution for the treatment of chronic obstructive pulmonary disease (COPD).”

ANDA • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Cipla receives final approval for generic version of Sunovion Pharmaceuticals, Inc.'s Brovana (Arformoterol Tartrate Inhalation Solution 15 mcg/ 2mL) (PRNewswire) - "Cipla Limited...announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL from the United States Food and Drug Administration (US FDA). Cipla's Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL is AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals Inc.'s Brovana®."

ANDA • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Glenmark Pharmaceuticals receives ANDA approval for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials (PRNewswire) - "Glenmark Pharmaceuticals Ltd (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials, the generic version of BROVANA® Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc. Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company's North American manufacturing facility based in Monroe, North Carolina, and marks the company's first nebulizer approval."

ANDA • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Lupin launches generic inhalation product in US market (The Hindu Business Line) - "Drug firm Lupin on Friday said it has launched Arformoterol Tartrate, an inhalation product to treat conditions like chronic bronchitis and emphysema, in the US market. The Mumbai-based company's product is the generic version of Sunovion Pharmaceuticals Inc's Brovana inhalation solution, Lupin said in a statement. Arformoterol Tartrate inhalation solution is indicated for the long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is for use by nebulisation only, the drugmaker noted."

Generic launch • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

AbbVie and Roche Will Be Hardest Hit by Patent Expirations (Gurufocus) - "Other among the top 10 drugs facing generic competitors this year are....Brovana from Suniovion Pharmaceuticals (private): 2020 U.S. sales projection: Around $275 million; Disease: Chronic obstructive pulmonary disease; Potential generic entry: Second half of 2021."

Generic launch • Sales projection • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

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

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

Nebulizer Versus Dry Powdered Inhalers for COPD (clinicaltrials.gov) - P4; N=40; Terminated; Sponsor: Wake Forest University Health Sciences; N=100 ➔ 40; Trial completion date: Mar 2021 ➔ Apr 2020; Recruiting ➔ Terminated; Trial primary completion date: Mar 2021 ➔ Apr 2020; Lower enrollment than Sponsor expected - Sponsor stopped study

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Obstructive Pulmonary Disease

Comparison table: Inhaled long-acting bronchodilators for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease