METHADONE HYDROCHLORIDE INTENSOL (methadone hydrochloride) · Hikma
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
LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL INGESTION, ABUSE POTENTIAL INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES, TREATMENT FOR OPIOID ADDICTION, and RISK EVALUATION AND MITIGATION STRATEGY (REMS) Life-Threatening Respiratory Depression Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients to methadone, and even when the drug has been used as recommended and not misused or abused...
WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL INGESTION, ABUSE POTENTIAL INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES, TREATMENT FOR OPIOID ADDICTION, and RISK EVALUATION AND MITIGATION STRATEGY (REMS) Life-Threatening Respiratory Depression Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients to methadone, and even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions ( 5.1 )] . Proper dosing and titration are essential and Methadone Hydrochloride Intensol ™ should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for detoxification and maintenance treatment of opioid addiction. Monitor for respiratory depression, especially during initiation of Methadone Hydrochloride Intensol ™ or following a dose increase. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak pharmacologic effect, especially during the initial dosing period. Managing Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, is a risk factor for respiratory depression and death [see Warnings and Precautions ( 5.2 )] . • Reserve concomitant prescribing of benzodiazepines or other CNS depressants in patients in methadone treatment to those for whom alternatives to benzodiazepines or other CNS depressants are inadequate. • Limit dosages and durations to the minimum required for patients being treated for pain. • Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation and consider delaying or omitting daily methadone dosing. Life-Threatening QT Prolongation QT interval prolongation and serious arrhythmia ( torsades de pointes ) have occurred
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 Oral Concentrate ( Intensol ™) contains methadone, an opioid agonist indicated for the: • Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use o Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions ] , reserve Methadone Hydrochloride Intensol ™ for use in patients for whom alternative analgesic treatme...
WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL INGESTION, ABUSE POTENTIAL INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES, TREATMENT FOR OPIOID ADDICTION, and RISK EVALUATION AND MITIGATION STRATEGY (REMS) Life-Threatening Respiratory Depr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.