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Naloxone Nasal Spray
Naloxone is a competitive opioid receptor antagonist that rapidly blocks opioid effects and reverses opioid overdose.
Naloxone is a competitive opioid receptor antagonist that rapidly blocks opioid effects and reverses opioid overdose. Used for Opioid overdose reversal (emergency treatment), Suspected or known opioid overdose with respiratory depression.
At a glance
| Generic name | Naloxone Nasal Spray |
|---|---|
| Sponsor | Pocket Naloxone Corp |
| Drug class | Opioid receptor antagonist |
| Target | Mu opioid receptor (primary); delta and kappa opioid receptors |
| Modality | Small molecule |
| Therapeutic area | Emergency Medicine / Toxicology |
| Phase | Phase 3 |
Mechanism of action
Naloxone binds with high affinity to mu, delta, and kappa opioid receptors, displacing opioids and preventing their activation. When administered intranasally, it is rapidly absorbed through the nasal mucosa and quickly crosses the blood-brain barrier to reverse respiratory depression and other life-threatening effects of opioid overdose. The nasal spray formulation provides a non-invasive, needle-free route of administration suitable for emergency use by laypersons.
Approved indications
- Opioid overdose reversal (emergency treatment)
- Suspected or known opioid overdose with respiratory depression
Common side effects
- Acute opioid withdrawal symptoms (agitation, body aches, sweating)
- Headache
- Nasal irritation
- Increased heart rate
- Hypertension
Key clinical trials
- Combination Gerotherapeutic Interventions for Healthspan Improvement (PHASE3)
- Neural Mechanisms of Immersive Virtual Reality in Chronic Pain (PHASE1, PHASE2)
- The Role of the Opioid System in Placebo Effects on Pain and Social Rejection (EARLY_PHASE1)
- Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF) (PHASE4)
- Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorders (PLI-MOUD) (NA)
- Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers. (PHASE1)
- Pharmacodynamic Evaluation of Intranasal Nalmefene (PHASE1)
- Neural Correlates of Hypoalgesia Driven by Observation (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Naloxone Nasal Spray CI brief — competitive landscape report
- Naloxone Nasal Spray updates RSS · CI watch RSS
- Pocket Naloxone Corp portfolio CI