Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 ...
Primatene Mist is used for the treatment of asthma. It is an investigational small molecule being developed by Amphastar Pharmaceuticals, Inc. for patients with asthma, including adolescents and adults aged 12 years and older.
Primatene Mist is a small molecule, but its specific molecular target is not disclosed in the available information. The drug is being studied for its safety in patients with asthma, though the exact mechanism of action has not been publicly detailed.
Primatene Mist is being developed by Amphastar Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol AMPH. The company is conducting clinical research on this drug for the treatment of asthma.
Primatene Mist is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under investigation for asthma.
Primatene Mist has one completed Phase 3 clinical trial, identified as NCT01476904, titled 'Safety Study in Adolescent and Adult Patients With Asthma.' This randomized, double-blind, placebo-controlled study enrolled 208 participants in the United States and included patients aged 12 years and older.
Primatene Mist is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The completed Phase 3 trial focused on safety in asthma patients, but approval status has not been granted based on the available information.