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Label indication Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic…
Also known as epinephrine inhalation aerosol, Epinephrine inhalation
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...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 27 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | tilrekimig and rHuPH20, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Epinephrine inhalation aerosol is being developed for the treatment of asthma. It is an inhaled small molecule formulation delivered as an aerosol, and it has been studied in adult and adolescent asthma patients. The program is investigational and has not been approved for marketing.
Epinephrine inhalation aerosol acts as an agonist at the alpha-1A, alpha-2A, alpha-2C, alpha-1D, beta-1, and beta-2 adrenergic receptors, also known as ADRA1A, ADRA2A, ADRA2C, ADRA1D, ADRB1, and ADRB2. Activation of these receptors produces bronchodilation and related airway effects relevant to asthma.
Amphastar Pharmaceuticals, Inc. is developing epinephrine inhalation aerosol. The company trades on the Nasdaq under the ticker AMPH. Amphastar has sponsored the clinical program evaluating this inhaled epinephrine formulation in asthma.
Epinephrine inhalation aerosol is in Phase 3 development. The program includes a completed Phase 3 efficacy and safety trial in asthma patients along with two completed Phase 1 pharmacokinetic studies. It remains an investigational product and is not approved for commercial use.
Three completed trials have studied epinephrine inhalation aerosol: NCT01357642, a Phase 3 efficacy and safety study in asthma patients; NCT01188577, a Phase 1 pharmacokinetic study; and NCT01143051, a Phase 1 pharmacokinetic study in healthy volunteers. All three trials were conducted in the United States.
Yes. Epinephrine inhalation aerosol is also known as HFA epinephrine, Epinephrine Inhalation Aerosol, and epinephrine inhalation. These names refer to the same Amphastar Pharmaceuticals product candidate, an HFA-propelled metered dose inhaler formulation of epinephrine being developed for asthma.