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Primatene Mist HFA · 1 trial · 1 indication
Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3. * Mean Maximum concentration of epinephrine (Cmax for epinephrine) * Mean Area Under the Curve (AUC) for epinephrine * Time to maximum concentration (tmax) and Half life of the drug (t1/2) * Epinephrine concentrations versus time
| Arm | Type | Description |
|---|---|---|
| Arm T1 Primatene Mist HFA | EXPERIMENTAL | epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes |
| Arm C Primatene Mist | ACTIVE_COMPARATOR | epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes |
| Arm T2 Primatene Mist HFA | EXPERIMENTAL | epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes |
| Name | Type | Description |
|---|---|---|
| Arm T1: Primatene Mist HFA | DRUG | epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes |
| Arm T2: Primatene Mist HFA | DRUG | epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes |
| Arm C: Primatene Mist (epinephrine inhalation aerosol, USP) | DRUG | epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes |
Inclusion Criteria: * Generally healthy at screening; * Body weight ≥ 50 kg for men and ≥ 45 kg for women; * Sitting blood pressure ≤ 135/90 mmHg; * Demonstrating negative hIV, HBsAG and DCV-Ab screen tests; * Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a cl...
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| 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 |
Primatene Mist HFA is an epinephrine inhalation aerosol being developed by Amphastar Pharmaceuticals, Inc. (ticker: AMPH) for asthma. It is a small molecule product delivered by inhalation. The program has completed a Phase 2 pharmacokinetics study in the United States, and the asset is investigational rather than an approved product.
Primatene Mist HFA is being studied for asthma, which falls within the respiratory therapeutic area. The clinical work completed to date enrolled adults with asthma in the United States. Because the program remains in clinical development, the drug has not been established as a marketed treatment for asthma.
Primatene Mist HFA is developed by Amphastar Pharmaceuticals, Inc., which trades under the ticker AMPH. The company is the sponsor behind the epinephrine inhalation aerosol program. Amphastar is a specialty pharmaceutical company, and this asset sits within its respiratory pipeline.
Primatene Mist HFA is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The completed study was a pharmacokinetics assessment of epinephrine inhalation aerosol USP conducted in the United States, so the asset remains investigational and is not an approved therapy.
Primatene Mist HFA has been evaluated in one completed Phase 2 trial, NCT01255709, titled Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS. The study enrolled 24 participants with asthma in the United States, was randomized, double blind, and used an active control.
Primatene Mist HFA is also referred to as Primatene Mist HFA, and the trial record labels the study arms as Arm T1: Primatene Mist HFA and Arm T2: Primatene Mist HFA. The program is an epinephrine inhalation aerosol developed by Amphastar Pharmaceuticals for asthma and remains in clinical development.