MedPath

Salbutamol

Generic Name
Salbutamol
Brand Names
Airomir, Airsupra, Combivent, Proair, Proventil, Ventolin
Drug Type
Small Molecule
Chemical Formula
C13H21NO3
CAS Number
18559-94-9
Unique Ingredient Identifier
QF8SVZ843E
Background

Salbutamol is a short-acting, selective beta2-adrenergic receptor agonist used in the treatment of asthma and COPD. It is 29 times more selective for beta2 receptors than beta1 receptors giving it higher specificity for pulmonary beta receptors versus beta1-adrenergic receptors located in the heart. Salbutamol is formulated as a racemic mixture of the R- and S-isomers. The R-isomer has 150 times greater affinity for the beta2-receptor than the S-isomer and the S-isomer has been associated with toxicity. This lead to the development of levalbuterol, the single R-isomer of salbutamol. However, the high cost of levalbuterol compared to salbutamol has deterred wide-spread use of this enantiomerically pure version of the drug. Salbutamol is generally used for acute episodes of bronchospasm caused by bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders such as chronic obstructive pulmonary disorder (COPD). It is also used prophylactically for exercise-induced asthma.

Indication

Salbutamol is indicated for (i) the symptomatic relief and prevention of bronchospasm due to bronchial asthma, chronic bronchitis, reversible obstructive airway disease, and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor, and/or (ii) the acute prophylaxis against exercise-induced bronchospasm and other stimuli known to induce bronchospasm.

Associated Conditions
Asthma, Asthmatic Bronchitis, Bronchial Asthma, Bronchoconstriction, Bronchospasm, Chronic Asthma, Chronic Bronchitis, Cough, Emphysema, Exacerbation of asthma, Exercise-Induced Bronchospasm, Hyperkalemia, Wheezing, Excess mucus or phlegm
Associated Therapies
Airway secretion clearance therapy, Bronchodilation

FTC Issues New Warnings to Teva and Novartis Over Improper Orange Book Patent Listings

• The Federal Trade Commission has renewed challenges against Novartis, Teva, and other pharmaceutical companies for allegedly improper patent listings in the FDA's Orange Book. • The disputed listings involve more than 200 patents across 17 brand-name products, primarily for asthma, diabetes, epinephrine autoinjectors, and COPD medications. • According to the FTC, these improper device patent listings may delay generic competition, artificially inflate drug prices, and restrict patient access to affordable medications.

Virtual Trial Shows Combination Rescue Inhaler Reduces Severe Asthma Attacks by Nearly 50%

• A groundbreaking virtual phase III trial found that Airsupra, combining budesonide and albuterol, reduced severe asthma exacerbations by 44% compared to albuterol alone in mild asthma patients. • The innovative fully remote trial design allowed 2,421 participants to receive inhalers by courier and meet investigators via telehealth, potentially revolutionizing future clinical research in pulmonary medicine. • Beyond reducing severe attacks, Airsupra decreased the annualized exacerbation rate by 53% and reduced systemic steroid exposure by 63%, potentially sparing patients from steroid-related complications.

BATURA Trial: Airsupra Reduces Severe Asthma Exacerbation Risk by 47% Compared to Albuterol Alone

• AstraZeneca's Airsupra (albuterol/budesonide) demonstrated a 47% reduction in severe asthma exacerbation risk compared to albuterol alone in patients with mild asthma, according to the Phase IIIb BATURA trial. • The anti-inflammatory rescue therapy reduced total systemic corticosteroid exposure by 63%, potentially decreasing risks associated with cumulative steroid use including diabetes, cardiovascular disease, and other adverse conditions. • Results were so overwhelmingly positive that the Independent Data Monitoring Committee recommended early termination of the trial, suggesting a potential paradigm shift in asthma rescue treatment after 50 years of albuterol-only standard care.

AstraZeneca to Present Groundbreaking Respiratory Research at ATS 2025 Conference

• AstraZeneca will showcase over 75 abstracts at the American Thoracic Society International Conference, highlighting advancements in asthma and COPD treatments including Airsupra and Breztri. • The BATURA Phase IIIb trial demonstrates Airsupra's potential to transform asthma rescue treatment by reducing systemic corticosteroid exposure compared to albuterol alone. • New data shows prompt initiation of Breztri after COPD exacerbations reduces subsequent exacerbations and cardiopulmonary events, addressing COPD as the third leading cause of death globally.

FDA Approves Ritedose's Albuterol Sulfate Inhalation Solution Amid National Shortage

• Ritedose Pharmaceuticals has received FDA approval for Albuterol Sulfate Inhalation Solution 0.5% (2.5 mg/0.5 mL), completing their portfolio of albuterol treatments amid a nationwide shortage that has persisted since October 2022. • The newly approved dosage will be manufactured using Blow-Fill-Seal technology in Ritedose's expanded facilities, with availability expected in the second quarter of 2025 to help address critical needs for over 26 million asthma patients. • This approval strengthens Ritedose's position as the largest provider of nebulizer products in the US, having delivered more than 4.5 billion doses throughout the company's history.

GSK to Present Groundbreaking Respiratory Medicine Data at ATS 2025 International Congress

• GSK will showcase 43 abstracts at the ATS 2025 International Congress, highlighting advancements in treatments for asthma and COPD with mepolizumab and depemokimab. • New MATINEE trial analyses demonstrate mepolizumab's effectiveness in reducing COPD exacerbations and hospitalizations across various patient subgroups, including those with cardiovascular comorbidities. • Twice-yearly dosing of depemokimab shows promising results in improving quality of life and reducing exacerbations in asthma patients with type 2 inflammation, potentially transforming treatment adherence.

Federal Circuit Rules Against Teva's Orange Book Patent Listings for ProAir HFA Inhaler

• The U.S. District Court ordered Teva Pharmaceuticals to remove its ProAir HFA inhaler device patents from the FDA's Orange Book, ruling they don't meet statutory listing requirements. • The Federal Circuit affirmed that patents must claim the drug's active ingredient to be Orange Book listable, rejecting Teva's argument that device component patents qualify. • The case, sparked by Amneal Pharmaceuticals' generic challenge, has drawn attention from major pharma companies and the FTC, potentially impacting future drug-device patent listings.

Biogen Secures $250M from Royalty Pharma to Advance Lupus Antibody into Phase III Trials

• Biogen has entered into a strategic funding agreement with Royalty Pharma, securing $250 million over six quarters to advance litifilimab, a promising lupus treatment, into Phase III development. • The BDCA2-targeting monoclonal antibody litifilimab showed significant reduction in joint pain for systemic lupus erythematosus patients in Phase II trials, with Phase III data expected between 2026-2027. • The deal includes milestone payments and mid-single-digit royalties on worldwide sales, coming at a crucial time as Biogen restructures its pipeline and faces various business challenges.
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