Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
naloxone AP003 · 1 trial · 1 indication
The mean naloxone plasma concentration during the two AP003 dosing periods.
The mean naloxone plasma concentration during the two Narcan dosing periods.
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE) by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of abnormal vital signs (heart rate, blood pressure, and respiration rate) by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of clinically significant ECG by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of clinical laboratory changes by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of adverse events of special interest (AESI) indicating of nasal irritation (erythema, edema, and erosion) by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of changes in B-SIT assessment within an AP003 period thru End of Study Visit (within 7 days after 2nd dose).
| Arm | Type | Description |
|---|---|---|
| Arm 1 Interventional Therapy | OTHER | Subjects will first receive 4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device (Arm 1) before the washout period. |
| Arm 2 Reference Therapy | OTHER | Subjects will first receive 2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device (reference therapy, Arm 2) before the washout period. |
| Name | Type | Description |
|---|---|---|
| 16 mg naloxone AP003 | COMBINATION_PRODUCT | 4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device |
| 8 mg naloxone NARCAN Nasal Spray | COMBINATION_PRODUCT | 2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device |
Inclusion Criteria: * Are able to consent and freely provide informed consent. * Females and males 18-55 years of age, inclusive. * Have a body mass index (BMI) less than or equal to 34.0 kg/m2. * Generally healthy, in the opinion of the Investigator, based on medical history, physical examination,...
Naloxone AP003 is an investigational intranasal formulation of naloxone being developed by Emergent BioSolutions Inc. (ticker: EBS) for opioid overdose. It is a small molecule product candidate that has completed a Phase 1 pharmacokinetics and safety trial in healthy adult volunteers in the United States.
Naloxone AP003 is being developed for opioid overdose. Its completed Phase 1 trial enrolled 24 healthy adult volunteers in the United States and evaluated the pharmacokinetics and safety of multiple intranasal doses. The drug is investigational and has not been approved for any indication.
Naloxone AP003 targets the opioid receptors OPRK1 (kappa), OPRD1 (delta), and OPRM1 (mu). It acts as an antagonist at these receptors. This receptor antagonism underlies its development for opioid overdose, where blocking opioid receptor activity is the intended pharmacological effect.
Naloxone AP003 is being developed by Emergent BioSolutions Inc., which trades under the ticker EBS. The company is the sponsor of the clinical program for this investigational intranasal naloxone product candidate.
Naloxone AP003 is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA or any other regulatory agency for opioid overdose or any other indication.
Naloxone AP003 has been studied in one completed Phase 1 trial, NCT05377255, titled Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults. The trial enrolled 24 healthy adult volunteers in the United States and used a randomized, controlled design.