Overview
Tapentadol is a centrally-acting synthetic analgesic with a dual mechanism of action. It is a mu-opioid receptor agonist that also inhibits norepinephrine reuptake. Tapentadol was first approved by the FDA on November 20, 2008. The extended-release formulation of tapentadol was also approved by the FDA on August 26, 2011. Used in the management of pain, tapentadol is typically reserved for patients who have limited alternative treatment options.
Background
Tapentadol is a centrally-acting synthetic analgesic with a dual mechanism of action. It is a mu-opioid receptor agonist that also inhibits norepinephrine reuptake. Tapentadol was first approved by the FDA on November 20, 2008. The extended-release formulation of tapentadol was also approved by the FDA on August 26, 2011. Used in the management of pain, tapentadol is typically reserved for patients who have limited alternative treatment options.
Indication
用于治疗严重到需要阿片类镇痛剂且替代治疗不充分的急性疼痛。
Associated Conditions
- Diabetic Peripheral Neuropathic Pain (DPN)
- Severe Acute Pain
- Severe Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/21 | Phase 4 | Recruiting | |||
2023/08/21 | Phase 4 | Completed | Kempegowda Institute of Medical Sciences, Bangalore | ||
2019/06/10 | Phase 1 | Completed | |||
2019/05/20 | Phase 1 | Completed | |||
2018/07/27 | Phase 4 | Completed | All India Institute of Medical Sciences, Bhubaneswar | ||
2017/11/24 | Not Applicable | Completed | All India Institute of Medical Sciences, Bhubaneswar | ||
2017/10/19 | Phase 4 | Completed | Oslo University Hospital | ||
2017/04/20 | Phase 1 | Completed | Frederiksberg University Hospital | ||
2015/11/13 | Phase 3 | Completed | St. Olavs Hospital | ||
2014/08/20 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| STAT RX USA LLC | 16590-889 | ORAL | 75 mg in 1 1 | 7/9/2010 | |
| Collegium Pharmaceutical, Inc. | 24510-075 | ORAL | 75 mg in 1 1 | 12/21/2023 | |
| Physicians Total Care, Inc. | 54868-6039 | ORAL | 100 mg in 1 1 | 5/9/2011 | |
| Quality Care Products, LLC | 55700-792 | ORAL | 50 mg in 1 1 | 9/18/2019 | |
| Stat Rx USA | 16590-863 | ORAL | 50 mg in 1 1 | 3/29/2010 | |
| Depo NF Sub, LLC | 69865-250 | ORAL | 150 mg in 1 1 | 9/24/2018 | |
| Quality Care Products, LLC | 55700-797 | ORAL | 100 mg in 1 1 | 9/26/2019 | |
| Depo NF Sub, LLC | 69865-210 | ORAL | 50 mg in 1 1 | 9/30/2018 | |
| Collegium Pharmaceutical, Inc. | 24510-291 | ORAL | 250 mg in 1 1 | 12/20/2023 | |
| Depo NF Sub, LLC | 69865-240 | ORAL | 50 mg in 1 1 | 9/24/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PALEXIA SR tapentadol (as hydrochloride) 250 mg sustained release tablet blister pack | 165357 | Medicine | A | 1/19/2011 | |
| PALEXIA IR tapentadol (as hydrochloride) 50 mg tablet blister pack | 165310 | Medicine | A | 11/22/2010 | |
| PALEXIA SR tapentadol (as hydrochloride)100 mg sustained release tablet blister pack | 165346 | Medicine | A | 1/19/2011 | |
| PALEXIA SR tapentadol (as hydrochloride)150 mg sustained release tablet blister pack | 165347 | Medicine | A | 1/19/2011 | |
| PALEXIA IR tapentadol (as hydrochloride) 75 mg tablet blister pack | 165317 | Medicine | A | 11/22/2010 | |
| PALEXIA SR tapentadol hydrochloride 25 mg sustained release tablet blister pack | 229737 | Medicine | A | 9/24/2015 | |
| PALEXIA SR tapentadol (as hydrochloride) 200 mg sustained release tablet blister pack | 165356 | Medicine | A | 1/19/2011 | |
| PALEXIA SR tapentadol (as hydrochloride) 50 mg sustained release tablet blister pack | 165332 | Medicine | A | 1/19/2011 | |
| PALEXIA IR tapentadol (as hydrochloride) 100 mg tablet blister pack | 165318 | Medicine | A | 11/22/2010 |