METHADONE HYDROCHLORIDE INTENSOL (methadone hydrochloride)
Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain in patients where alternative treatments, such as immediate-release opioids, are ineffective or poorly tolerated. It is also indicated for the temporary treatment of opioid dependence in hospitalized patients or those in clinical settings who are unable to take oral medication. Due to the risks of addiction, abuse, and fatal overdose, its
How METHADONE HYDROCHLORIDE INTENSOL Works
This drug works by acting as a mu-agonist, a synthetic opioid that targets the central nervous system and smooth muscle to produce effects similar to morphine. It provides a slower onset and more prolonged course than morphine, leading to a less severe abstinence syndrome during detoxification. Additionally, it may act as an antagonist at the NMDA receptor, though the specific therapeutic contribution of this action is unclear.
Details
- Status
- Prescription
- First Approved
- 1988-09-06
- Routes
- ORAL
- Dosage Forms
- CONCENTRATE
METHADONE HYDROCHLORIDE INTENSOL Approval History
What METHADONE HYDROCHLORIDE INTENSOL Treats
2 indicationsMETHADONE HYDROCHLORIDE INTENSOL is approved for 2 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Opioid Dependence
METHADONE HYDROCHLORIDE INTENSOL Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE INJECTION Addiction, Abuse, and Misuse Because the use of Methadone Hydrochloride Injection 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 METHADONE HYDROCHLORIDE INJECTION Addiction, Abuse, and Misuse Because the use of Methadone Hydrochloride Injection 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 Methadone Hydrochloride Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Methadone Hydrochloride Injection are essential (see WARNINGS ). Neonatal Opioid Withdrawal Syndrome (NOWS) Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of Methadone Hydrochloride Injection during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. The balance between the risks of NOWS and the benefits of maternal Methadone Hydrochloride Injection use may differ based on the risks associated with the mother’s underlying condition, pain, or addiction. Advise the patient of the risk of NOWS so that appropriate planning for management of the neonate can occur (see WARNINGS ). Managing 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 Methadone Hydrochloride Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate (see WARNINGS , PRECAUTIONS ). Life-Threatening QT Prolongation QT interval prolongation and serious arrhythmia (torsades de pointes) hav
METHADONE HYDROCHLORIDE INTENSOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 METHADONE HYDROCHLORIDE INTENSOL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06962306 OPAL-Cleft | Pro00117598 | Ph 4 | recruiting | Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery |
| NCT07226076 | Pro00147447 | Ph 3 | recruiting | Methadone in TKA for Post-op Pain and Opioid Reduction |
| NCT06877858 | 857972 | Ph 1 | recruiting | MethaLoad Dose-Finding Study |
| NCT06086171 | SHS-An-4-2023 | Ph 4 | completed | Perioperative Methadone Compared to Placebo in Elderly Hip Fracture Patients |
| NCT05831345 | CHUB-Methadone | Ph 3 | recruiting | Intraoperative Methadone for the Prevention of Postoperative Pain |
| NCT04680286 METACEBO | 23956082 2020-002945-41 | Ph 3 | terminated | Intraoperative Methadone in Children Undergoing Surgery |
| NCT00930332 | SC22 CAN-NCIC-SC22, CDR0000641372 | Ph 1 | terminated | Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain |
| NCT02989597 MAPS results posted | 2016-6985 | Ph 4 | terminated | Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients |
| NCT02531906 | I 262314 NCI-2015-01338, I 262314 | Ph 1 | completed | Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation |
| NCT01795495 results posted | IRB13-0036 Active | Ph 2 | completed | Methadone vs Magnesium in Spinal Fusion |
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.
METHADONE HYDROCHLORIDE INTENSOL FDA Label Details
Indications & Usage
FDA Label (PDF)METHADONE HYDROCHLORIDE INTENSOL is indicated for the treatment of Pain; Opioid Dependence.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE INJECTION Addiction, Abuse, and Misuse Because the use of Methadone Hydrochloride Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, asse...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.