Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
A: Epinephrine · 1 trial · 2 indications
Plasma level of Epinephrine
Pharmacodynamic response
Pharmacodynamic response
Pharmacodynamic response
| Arm | Type | Description |
|---|---|---|
| 6 Healthy volunteers, sequence ABC | EXPERIMENTAL | Three drug administrations to each subject, each administration on a separate day. treatment order: A B C |
| 6 Healthy volunteers, sequence BAC | EXPERIMENTAL | Three drug administrations to each subject, each administration on a separate day. treatment order: B A C |
| Name | Type | Description |
|---|---|---|
| A: Epinephrine injection | DRUG | Autoinjector for intramuscular, single-use, 0.3mg |
| B: FMXIN002 3.6mg | DRUG | Nasus Pharma nasal powder spray 3.6 mg, single use in one nostril |
| C: FMXIN002 4.0mg | DRUG | Nasus Pharma nasal powder spray 4.0 mg, single use in one nostril |
Inclusion Criteria: * 1\) Non-smoking, male and female subjects from 18 to 55 years of age. 2) BMI ≥18 \< 30 kg/m2. 3) Females may be of childbearing or non-childbearing potential: * Childbearing potential: o Physically capable of becoming pregnant, must be willing to use acceptable effecti...
Epinephrine is used for the treatment of anaphylaxis, a severe and potentially life-threatening allergic reaction. It is being developed as an intranasal formulation by Nasus Pharma Ltd. The drug is currently in Phase 1 clinical development and is intended to provide a needle-free option for emergency treatment of anaphylactic reactions.
Epinephrine works by acting on alpha and beta adrenergic receptors to reverse the effects of anaphylaxis. It causes vasoconstriction, which reduces swelling and increases blood pressure, and bronchodilation, which improves breathing. It also decreases the release of inflammatory mediators from mast cells and basophils, counteracting the allergic response.
Epinephrine is being developed by Nasus Pharma Ltd., a biopharmaceutical company. The company is focused on developing intranasal formulations of drugs for emergency use. Nasus Pharma is publicly traded under the ticker symbol NSRX.
Epinephrine is in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the comparative bioavailability of intranasal epinephrine in healthy volunteers. The drug is investigational and has not yet been approved by regulatory authorities.
Epinephrine has one completed Phase 1 clinical trial, NCT06205134, titled "Comparative Bioavailability of Intranasal Epinephrine." This trial enrolled 12 participants in Israel and studied the drug's bioavailability in healthy volunteers. The trial was controlled but not double-blinded, and it included both male and female participants aged 18 years and older.
Epinephrine is also known as adrenaline. The drug is being developed as an intranasal formulation for the emergency treatment of anaphylaxis. In clinical trials, it is referred to as intranasal epinephrine, and it is being studied for its bioavailability compared to other forms of administration.