Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
E004 HFA-MDI · 1 trial · 1 indication
bronchodilator effect expressed as AUC of FEV1's relative change (from the same day baseline) versus time, defined as AUC of ΔFEV1%.
| Arm | Type | Description |
|---|---|---|
| P - Placebo-HFA | PLACEBO_COMPARATOR | Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
| T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI | EXPERIMENTAL | E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
| Name | Type | Description |
|---|---|---|
| E004 (Epinephrine Inhalation Aerosol) HFA-MDI | DRUG | E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
| Placebo-HFA | DRUG | Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
Inclusion Criteria: * Generally healthy male, and premenarchal female, children aged 4 - 11 years upon Screening. * With documented asthma, requiring inhaled epinephrine or beta2-agonist treatment, with or without concurrent anti-inflammatory therapies for at least 6-months prior to Screening. * Be...
E004 HFA-MDI is an investigational small molecule being developed for the treatment of asthma. It is delivered as a metered-dose inhaler with hydrofluoroalkane propellant. The drug is currently in Phase 3 clinical development and has been evaluated in a completed trial involving children with asthma.
E004 HFA-MDI is being developed by Amphastar Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol AMPH. The drug is currently in Phase 3 clinical development for the treatment of asthma.
E004 HFA-MDI is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial evaluating its efficacy and safety in children with asthma has been completed.
E004 HFA-MDI has been studied in one clinical trial, identified as NCT01460511, titled 'Evaluation of Efficacy and Safety of E004 in Children With Asthma.' This Phase 3 trial was completed and enrolled 70 participants in the United States.
E004 HFA-MDI is the name used in clinical trials for this investigational asthma treatment. No alternative names have been reported for this drug. It is being developed by Amphastar Pharmaceuticals, Inc. and is currently in Phase 3 clinical development.