MITIGO (morphine sulfate)
MITIGO is indicated for the treatment of Chronic Pain.
Details
- Status
- Prescription
- First Approved
- 2018-07-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
MITIGO Approval History
What MITIGO Treats
1 indicationsMITIGO is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Pain
MITIGO Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MITIGO ® WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MITIGO ® Risks with Neuraxial Administration Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when MITIGO ® is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the ...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MITIGO ® WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MITIGO ® Risks with Neuraxial Administration Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when MITIGO ® is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose [see Warnings and Precautions ( 5.1 ) ] . Addiction, Abuse, and Misuse Because the use of MITIGO ® 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 and Precautions ( 5.2 )] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of MITIGO ® , especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of MITIGO ® are essential [see Warnings and Precautions ( 5.3 ) ] . 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 MITIGO ® and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.4 ), Drug Interactions ( 7 )] . Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk Neonatal Opioid Withdrawal Syndrome, which may be life threatening if not recognized and treated. Ensure that management by n
MITIGO 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.
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Clinical Trial Registry
29 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04429516 PAciFy Cough results posted | RBH2019/001 2019-003571-19 | Ph 3 | completed | Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough |
| NCT05324358 | NTM-001-CT001 | Ph 3 | suspended | Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy |
| NCT04772222 DICE results posted | 136561 | Ph 2 | completed | Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial) |
| NCT05351229 | IRB22-0561 | Ph 4 | recruiting | Intrathecal Morphine for Analgesia in Video-assisted and Robotic-assisted Thoracic Surgery |
| NCT04110665 Shoulder1 | Local/2017/PC-03 2017-A01316-47 | Ph 4 | completed | Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery |
| NCT05069012 results posted | 2021P000688 | Ph 4 | completed | Intrathecal Morphine for Cesarean Delivery |
| NCT07054775 | HE631484 | Ph 4 | recruiting | Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section |
| NCT03092011 | 16-144 | Ph 4 | active not recruiting | Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy |
| NCT06160778 KETOAPP | 23-0952 | Ph 3 | recruiting | Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain |
| NCT05630222 | 3401308 | Ph 3 | completed | Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen |
| NCT05251376 | LYN-014-C-101 4UH3DA050310-02 | Ph 1 | withdrawn | Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy |
| NCT03088826 results posted | 2017-01-05 | Ph 2 | completed | Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet) |
| NCT04688814 | 0304884 | Ph 3 | completed | SEQ Block for Perioperative Analgesia in Acetabular Surgery |
| NCT03483870 | Granisetron in C.S | Ph 2 | completed | Effect of Granisetron on Morphine Induced Pruritus in Cesarean Section |
| NCT04301336 | Novel TTT of pedia VOC/SCA | Ph 2, Ph 3 | completed | Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia |
| NCT03809182 results posted | Dexmedetomidine and glycemia. | Ph 4 | completed | Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. |
| NCT02720822 BEAMS | 030/15 | Ph 3 | completed | Breathlessness Exertion and Morphine Sulphate |
| NCT03429400 | MORP-OS+T-(2-17)-SPK-2 | Ph 3 | completed | Study of Oral Morphine Sulfate Administration in Pediatric Subjects |
| NCT02869321 ANTALGIP | 2014-003352-32 | Ph 4 | completed | Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy |
| NCT01708707 | Banner IRB 01-13-0030 | Ph 2 | completed | Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS) |
| NCT01322360 results posted | MORP-OS+T-(2-17)-SPK-1 | Ph 4 | completed | Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects |
| NCT01871285 results posted | EN3409-204 | Ph 2 | completed | Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film |
| NCT02455362 | 022/13 V.3.2.3 | Ph 3 | withdrawn | Opioids for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease |
| NCT01507220 IMPROVE-Open results posted | MA402S23B301 | Ph 4 | terminated | A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301 |
| NCT00901628 results posted | B-0804/056-021 | Ph 4 | completed | Periarticular Multimodal Drug Injections in Total Knee Arthroplasty |
| NCT01016808 | Q8003-008 | Ph 3 | completed | Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients |
| NCT00831051 | Q8003-021 | Ph 2 | completed | Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients |
| NCT01280331 | Q8003-022 | Ph 3 | completed | Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients |
| NCT00678145 results posted | 2012-665 R01DK079974 | Ph 2 | terminated | Mechanisms of Hypoglycemia Associated Autonomic Failure |
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.
MITIGO FDA Label Details
Indications & Usage
MITIGO is indicated for the treatment of Chronic Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MITIGO ® WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MITIGO ® Risks with Neuraxial Administration Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of seve...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.