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Label indication Albuterol Sulfate HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. FDA label
Albuterol · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | NISOLDIPINE EXTENDED-RELEASE TABLETS, 40 MG |
| 2 | ACTIVE_COMPARATOR | Sular® Extended Release 40 mg tablets |
| Name | Type | Description |
|---|---|---|
| Albuterol Sulfate Extended-Release Tablets 8 mg | DRUG | 8mg, single dose fed |
| VoSpire® ER Tablets 8 mg | DRUG | 8mg, single dose fed |
| albuterol sulfate extended-release 8 mg tablets | DRUG | 8mg, single dose fasting |
| VoSpire™ ER 8 mg tablets | DRUG | 8mg, single dose fasting |
I. Inclusion Criteria: Subjects who met the following criteria were included in the study. 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test perfor...
Albuterol sulfate extended-release 8 mg tablets are an investigational oral formulation of albuterol, a small-molecule beta-2 adrenergic receptor agonist. The extended-release tablet is designed to release the drug over time rather than immediately. Viatris Inc. (VTRS) is developing this formulation, which has been studied in Phase 1 bioequivalence trials in healthy volunteers.
Albuterol targets ADRB2, the beta-2 adrenergic receptor. It acts as an agonist at this receptor, meaning it activates the receptor. ADRB2 agonism is the established mechanism for albuterol, a bronchodilator used in airway conditions. The extended-release tablet formulation is being developed by Viatris Inc. (VTRS) as an oral version of this small molecule.
Viatris Inc. (ticker VTRS) is the developer of albuterol sulfate extended-release 8 mg tablets. The company has sponsored Phase 1 clinical trials of this oral extended-release formulation, including bioequivalence studies comparing it with VoSpire ER tablets in healthy adult volunteers.
Albuterol sulfate extended-release 8 mg tablets are in Phase 1 clinical development. The program has completed three Phase 1 trials with a total enrollment of 90 participants. The studies were randomized and active-controlled, conducted in the United States in healthy volunteers aged 18 years and older.
Three completed Phase 1 trials have studied albuterol sulfate extended-release 8 mg tablets: NCT00649987, a fed bioequivalence study with 21 participants; NCT00649779, a fasting bioequivalence study with 21 participants; and NCT00730197, a fasting bioequivalence study with 48 participants. All enrolled healthy adults in the United States.
Albuterol sulfate extended-release 8 mg tablets were compared with VoSpire ER tablets 8 mg in Phase 1 bioequivalence studies. VoSpire ER is a reference extended-release albuterol product used as the comparator in these trials. The studies evaluated both fed and fasting bioequivalence between the two formulations in healthy volunteers.