Approval Probability
TA Base Rate
Adjusted LOA
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Nasus Pharma FMXIN001 · 1 trial · 1 indication
Pharmacokinetic Parameters
Pharmacokinetic Parameters
Pharmacokinetic Parameters
Pharmacokinetic Parameters
Pharmacokinetic Parameters
| Arm | Type | Description |
|---|---|---|
| FMXIN001 4 mg Naloxone microspheres powder, | EXPERIMENTAL | Naloxone powder nasal spray from Nasus Pharma, Israel |
| Narcan® 4 mg/0.1 mL nasal spray | ACTIVE_COMPARATOR | Naloxone solution nasal spray from Adapt Pharma, Inc., USA |
| Name | Type | Description |
|---|---|---|
| Nasus Pharma FMXIN001 | COMBINATION_PRODUCT | A nasal spray of 4mg Naloxone Hydrochloride powder in a unit dose device |
| Nasal Naloxone liquid spray | COMBINATION_PRODUCT | A nasal spray of 4mg/0.1mL Naloxone Hydrochloride solution in a unit dose device |
Inclusion Criteria: 1. Healthy, non-smoking, male and female subjects, 18 years of age or older. 2. BMI ≥18 and ≤30 kg/m2. 3. Females may be of childbearing or non-childbearing potential: * Childbearing potential: o Physically capable of becoming pregnant * Non-childbearing potential: ...
Nasus Pharma FMXIN001 is an investigational small molecule being developed for the treatment of opioid overdose. It is formulated as a 4 mg microspheres powder for intranasal delivery. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Nasus Pharma FMXIN001 is being developed by Nasus Pharma Ltd., a biopharmaceutical company. The company's ticker symbol is NSRX. The drug is in Phase 1 clinical development for opioid overdose.
Nasus Pharma FMXIN001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug remains under investigation for the treatment of opioid overdose.
Nasus Pharma FMXIN001 has one completed Phase 1 clinical trial, NCT04713709, titled 'A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder.' The trial enrolled 46 healthy volunteers in Canada and was an active-controlled, randomized study.
Nasus Pharma FMXIN001 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for opioid overdose. The drug has completed one Phase 1 trial, but it has not received regulatory approval.