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Label indication Uses for temporary relief of mild symptoms of intermittent asthma ■ wheezing ■ tightness of chest ■ shortness of breath FDA label
Also known as Arm C-Epinephrine Inhalation Aerosol CFC, epinephrine inhalation aerosol
Primatene Mist · 1 trial · 1 indication
Recording of all adverse events experienced during the course of the study
| Arm | Type | Description |
|---|---|---|
| Arm T | EXPERIMENTAL | Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals |
| Arm P | PLACEBO_COMPARATOR | Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals |
| Arm A | ACTIVE_COMPARATOR | Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 0 mcg/inhalation, 2 inhalations QID |
| Primatene Mist | DRUG | 220 mcg/inhalation, 2 inhalations QID |
| Epinephrine inhalation | DRUG | 125 mcg/inhalation, 2 inhalations QID |
Inclusion Criteria: * Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation * Male and female asthma patients aged 12 - 75 years * Patients with documented ...
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 | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, 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 is an epinephrine inhalation aerosol, USP, developed for the treatment of asthma. It is studied in adolescent and adult patients with asthma. The clinical program includes a Phase 3 safety study conducted in the United States.
Primatene Mist is developed by Amphastar Pharmaceuticals, Inc., which trades under the ticker AMPH. The company is the sponsor of the clinical program for this epinephrine inhalation aerosol product.
Primatene Mist is in Phase 3 clinical development for asthma. One Phase 3 trial has been completed, and no active trials are currently listed. The completed study was a randomized, double-blind, placebo-controlled safety study.
Primatene Mist has been evaluated in the Phase 3 trial NCT01476904, titled Safety Study in Adolescent and Adult Patients With Asthma. The trial enrolled 208 participants, was placebo-controlled, randomized, and double-blind, and has been completed.
Yes. Primatene Mist is also referred to as Arm C: Primatene Mist (epinephrine inhalation aerosol, USP) and Arm C: Primatene Mist. These names refer to the same epinephrine inhalation aerosol product developed by Amphastar Pharmaceuticals for asthma.