Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epinephrine HFA-MDI · 1 trial · 1 indication
Bronchodilator effect expressed as AUC of FEV1's relative change from the same day baseline (pre-dose) versus time up to 3 hours, defined as AUC(0-3) of change in FEV1%. The difference of primary endpoints of E004 and Placebo will be evaluated statistically.
| Arm | Type | Description |
|---|---|---|
| Arm T | EXPERIMENTAL | Experimental arm utilizing Epinephrine HFA-MDI (E004) |
| Arm P | PLACEBO_COMPARATOR | Placebo comparator arm utilizing Placebo-HFA |
| Name | Type | Description |
|---|---|---|
| Epinephrine HFA-MDI (E004) | DRUG | Single dose 125 mcg/inhalation, 2 inhalations |
| Placebo-HFA | DRUG | Single dose 0 mcg/inhalation, 2 inhalations |
Inclusion Criteria: * Generally healthy male, and premenarchal female, children ages 4 - 11 years upon Screening. * With documented asthma, requiring inhaled epinephrine or β2-agonist treatment, with or without concurrent anti-inflammatory therapies including orally inhaled corticosteroids, for at ...
Epinephrine HFA-MDI is an investigational small molecule being developed for the treatment of asthma. It is a hydrofluoroalkane metered-dose inhaler formulation of epinephrine intended for inhalation. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Epinephrine HFA-MDI is being developed by Amphastar Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol AMPH. The company is conducting clinical trials to evaluate the drug's efficacy and safety for the treatment of asthma.
Epinephrine HFA-MDI is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The drug is being studied for the treatment of asthma, and its safety and efficacy are still being evaluated in clinical trials.
Epinephrine HFA-MDI has one completed Phase 3 clinical trial, identified as NCT01737905. This study evaluated the efficacy and safety of a single dose of E004 in children with asthma. The trial was a randomized, double-blind, placebo-controlled study conducted in the United States with 28 participants.
Yes, Epinephrine HFA-MDI is also known as E004. In clinical trial NCT01737905, the drug is referred to as E004. This alternative name is used in the study title and may appear in related research publications and regulatory documents.