NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (naloxone hydrochloride)
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE is indicated for the treatment of Pain.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1997-01-21
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE Approval History
What NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE Treats
1 indicationsNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF PENTAZOCINE AND NALOXONE TABLETS Addiction, Abuse, and Misuse Because the use of Pentazocine and Naloxone Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [ see <WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-thre...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF PENTAZOCINE AND NALOXONE TABLETS Addiction, Abuse, and Misuse Because the use of Pentazocine and Naloxone Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [ see <WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Pentazocine and Naloxone Tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Pentazocine and Naloxone Tablets are essential [ see <WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of Pentazocine and Naloxone Tablets, especially by children, can result in a fatal overdose of Pentazocine Hydrochloride [ see <WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Pentazocine and Naloxone Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings , Precautions; Drug Interactions]. Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be lifethreatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [ see <WARNINGS ]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS compliant education program and to counsel pa
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07459166 | CS-1103-03 5UG3DA059286 | Ph 2 | not yet recruiting | A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade |
| NCT04828005 results posted | OPNT003-PD-001 | Ph 1 | completed | Pharmacodynamic Evaluation of Intranasal Nalmefene |
| NCT04473950 results posted | Z-1902 R21DA047520 | Ph 1 | terminated | The Effect of Chronic Pain on Delay Discounting in Methadone Patients |
| NCT05338632 ROAR | P21.112 | Ph 1 | recruiting | Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE FDA Label Details
Indications & Usage
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE is indicated for the treatment of Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF PENTAZOCINE AND NALOXONE TABLETS Addiction, Abuse, and Misuse Because the use of Pentazocine and Naloxone Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment