Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
epinephrine · 3 trials · 4 indications
Serial FEV1 measurements to demonstrate the mean AUC of change in percent FEV1 from same-day baseline of E004 (Treatment T; Epinephrine-HFA) versus Placebo-HFA (Treatment P) is the primary efficacy endpoint.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC\[0-6\]) was calculated using the trapezoidal rule.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine to decrease to half the peak concentration in plasma during the treatment period.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC\[0-6\]) was calculated using the trapezoidal rule.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.
Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period.
| Arm | Type | Description |
|---|---|---|
| Arm T | EXPERIMENTAL | Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals |
| Arm P | PLACEBO_COMPARATOR | Placebo comparator as 2×Placebo QID, with 4-6 hr intervals |
| Arm A | ACTIVE_COMPARATOR | Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals |
| Epinephrine Inhalation Aerosol, HFA | EXPERIMENTAL | Experimental treatment of 10 inhalations of 125 mcg epinephrine base propelled by HFA 134a |
| Epinephrine Inhalation Aerosol, CFC | ACTIVE_COMPARATOR | Epinephrine Inhalation Aerosol, CFC propelled, 220 mcg/inhalation , 10 inhalations |
| Treatment C | ACTIVE_COMPARATOR | Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose. |
| Treatment 1 | EXPERIMENTAL | T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation |
| Treatment 2 | EXPERIMENTAL | HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation |
| Name | Type | Description |
|---|---|---|
| Epinephrine inhalation aerosol | DRUG | Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals |
| Placebo | DRUG | Placebo for epinephrine inhalation aerosol, formulation without epinephrine |
| Epinephrine Inhalation Aerosol, HFA | DRUG | 10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation |
Inclusion Criteria: * Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment. * No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening * Can tolerate withholding treatment with inhaled...
Epinephrine is an investigational small molecule being developed by Amphastar Pharmaceuticals, Inc. (AMPH) for the treatment of asthma. It is formulated as an inhalation aerosol and is currently in Phase 3 clinical development. The drug is intended to relieve asthma symptoms, including bronchospasm, wheezing, and shortness of breath.
Epinephrine works by acting on alpha and beta adrenergic receptors, which are part of the sympathetic nervous system. This action leads to bronchodilation, relaxing the smooth muscles of the airways and improving airflow in patients with asthma. The drug is delivered via inhalation aerosol to target the lungs directly.
Epinephrine is being developed by Amphastar Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMPH. The company is conducting clinical trials to evaluate the safety and efficacy of this inhaled epinephrine formulation for the treatment of asthma.
Epinephrine is in Phase 3 clinical development for asthma. The most advanced trial, NCT01357642, is a Phase 3 study that has been completed. This trial evaluated the efficacy and safety of epinephrine inhalation aerosol in asthma patients aged 12 years and older. The drug is not yet approved and remains investigational.
Epinephrine has been studied in three clinical trials, all completed. NCT01143051 and NCT01188577 were Phase 1 pharmacokinetic studies in healthy volunteers, while NCT01357642 was a Phase 3 efficacy and safety study in asthma patients. The Phase 3 trial enrolled 373 participants and was conducted in the United States.
Epinephrine is a bronchodilator that has been used for decades in various forms, but this specific inhaled aerosol formulation is being developed by Amphastar. It is not the same as other common asthma medications like albuterol, which is a selective beta-2 agonist. Epinephrine acts on both alpha and beta receptors, providing a different mechanism of action.