Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Arm T1: 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...
Primatene Mist HFA is used for the treatment of asthma. It is an investigational small molecule being developed by Amphastar Pharmaceuticals, Inc. (AMPH). The drug is currently in Phase 2 clinical development, and it has been studied in a completed clinical trial involving patients with asthma.
Primatene Mist HFA targets the beta-2 adrenergic receptor, which is a type of receptor found in the lungs. By activating this receptor, the drug helps to relax and open the airways, which can relieve asthma symptoms. This mechanism is typical of bronchodilators used in asthma treatment.
Primatene Mist HFA is being developed by Amphastar Pharmaceuticals, Inc., a company publicly traded under the ticker symbol AMPH. The drug is currently in Phase 2 clinical trials for the treatment of asthma, and it is an investigational product that has not yet been approved by regulatory authorities.
Primatene Mist HFA is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, active-controlled study. The drug is still investigational and has not been approved by the FDA for commercial use.
Primatene Mist HFA has been studied in one completed clinical trial with the identifier NCT01255709. This trial was a Phase 2 study titled 'Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS.' It enrolled 24 participants with asthma in the United States, including healthy volunteers, and was randomized and double-blind.
Primatene Mist HFA is an epinephrine inhalation aerosol. The active ingredient in the drug is epinephrine, which is a medication used to relax muscles in the airways and improve breathing. The drug is being developed by Amphastar Pharmaceuticals for the treatment of asthma.