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Naloxone HCl PR tablets
Naloxone HCl is a competitive opioid receptor antagonist that blocks the effects of opioids by binding to opioid receptors without activating them.
Naloxone HCl is a competitive opioid receptor antagonist that blocks the effects of opioids by binding to opioid receptors without activating them. Used for Opioid overdose reversal, Opioid use disorder maintenance treatment, Prevention of opioid overdose in at-risk populations.
At a glance
| Generic name | Naloxone HCl PR tablets |
|---|---|
| Sponsor | Develco Pharma Schweiz AG |
| Drug class | Opioid antagonist |
| Target | Opioid receptors (mu, delta, kappa) |
| Modality | Small molecule |
| Therapeutic area | Addiction Medicine / Emergency Medicine |
| Phase | Phase 3 |
Mechanism of action
Naloxone competitively binds to mu, delta, and kappa opioid receptors with highest affinity for mu receptors, displacing opioids and preventing their pharmacological effects. The PR (prolonged-release) formulation extends the duration of action, allowing for less frequent dosing compared to immediate-release naloxone. This is particularly useful for chronic opioid overdose prevention and opioid use disorder management.
Approved indications
- Opioid overdose reversal
- Opioid use disorder maintenance treatment
- Prevention of opioid overdose in at-risk populations
Common side effects
- Withdrawal symptoms (agitation, body aches, anxiety)
- Headache
- Nausea
- Tachycardia
- Hypertension
Key clinical trials
- Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain (PHASE3)
- OXN PR Tablet 5/2.5 mg and20/10 mg PK Study in Chinese Moderate to Severe Chronic Non-malignant Patients (PHASE1)
- OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS) (PHASE2)
- A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy (PHASE3)
- Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms (PHASE3)
- OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects (PHASE3)
- Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation (PHASE3)
- To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain (PHASE2, PHASE3)
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 HCl PR tablets CI brief — competitive landscape report
- Naloxone HCl PR tablets updates RSS · CI watch RSS
- Develco Pharma Schweiz AG portfolio CI