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Revex (NALMEFENE)
Revex (nalmeftene) is a small molecule opioid antagonist that targets the kappa-type opioid receptor. Originally developed by EUROHLTH INTL SARL, it was approved by the FDA in 1995 for the treatment of alcoholism, opiate-induced respiratory depression, and poisoning by opiate analgesic drugs. As an off-patent medication, Revex is available as a generic product from multiple manufacturers. Key safety considerations include its half-life of 8.8 hours and bioavailability of 40%. Revex is a commercial product with a stable market presence.
At a glance
| Generic name | NALMEFENE |
|---|---|
| Sponsor | Hikma |
| Drug class | Opioid Antagonist |
| Target | Kappa-type opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1995 |
| Annual revenue | 400 |
Approved indications
- Alcoholism
- Opiate-Induced Respiratory Depression
- Poisoning by opiate analgesic drug
Common side effects
- Nausea
- Vomiting
- Tachycardia
- Hypertension
- Postoperative pain
- Fever
- Dizziness
- Headache
- Hypotension
- Vasodilation
- Chills
- Bradycardia
Key clinical trials
- Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia (PHASE4)
- Nalmefene Implant in Healthy Subjects (PHASE1)
- Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation (PHASE1)
- TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis (PHASE2)
- Pharmacodynamic Evaluation of Intranasal Nalmefene (PHASE1)
- Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg (PHASE1)
- An Evaluation of The Absolute Bioavailability of TH104 (PHASE1)
- Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Revex CI brief — competitive landscape report
- Revex updates RSS · CI watch RSS
- Hikma portfolio CI