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Brovana (ARFORMOTEROL)
Brovana works by activating the beta-2 adrenergic receptor to relax airway muscles and improve breathing.
Brovana (Arformoterol) is a small molecule beta2-adrenergic agonist developed by Sunovion and currently owned by Lupin. It targets the beta-2 adrenergic receptor to treat chronic bronchitis, chronic obstructive lung disease, and pulmonary emphysema. Brovana was FDA-approved in 2006 and is now off-patent with 17 generic manufacturers. Its long half-life of 26 hours allows for once-daily dosing. As a beta2-agonist, Brovana is a bronchodilator that helps relax airway muscles to improve breathing.
At a glance
| Generic name | ARFORMOTEROL |
|---|---|
| Sponsor | Lupin |
| Drug class | beta2-Adrenergic Agonist |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2006 |
Mechanism of action
Arformoterol, the (R,R)-enantiomer of formoterol, is selective long-acting beta2adrenergic receptor agonist (beta2-agonist) that has two-fold greater potency than racemic formoterol (which contains both the (S,S) and (R,R)-enantiomers). The (S,S)-enantiomer is about 1,000-fold less potent as beta2-agonist than the (R,R)-enantiomer. While it is recognized that beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the heart, data indicate that there are also beta2receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects.The pharmacologic effects of beta2-adrenoceptor agonist drugs, including arformoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, t
Approved indications
- Chronic bronchitis
- Chronic obstructive lung disease
- Pulmonary emphysema
Common side effects
- Pain
- Chest Pain
- Back Pain
- Diarrhea
- Sinusitis
- Leg Cramps
- Dyspnea
- Rash
- Flu Syndrome
- Peripheral Edema
- Lung Disorder
- Nausea
Key clinical trials
- Study in Adult Patients With Moderate to Severe Asthma (PHASE3)
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)
- Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
- Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting
- A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation (PHASE4)
- Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients (PHASE3)
- Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Brovana CI brief — competitive landscape report
- Brovana updates RSS · CI watch RSS
- Lupin portfolio CI