Overview
Sufentanil is an opioid analgesic that is used as an adjunct in anesthesia, in balanced anesthesia, and as a primary anesthetic agent. It is administered by the intravenous, epidural and sublingual routes. Also known as Dsuvia, the sublingual form is used for the management of acute pain in adults that is severe to warrant the use of an opioid analgesic in certified medically supervised healthcare settings, including hospitals, surgical centers, and emergency departments . Consideration may be made in the future for the use of the sublingual form in the US military in cases where analgesia is required immediately . The sublingual form, manufactured by AcelRx Pharmaceuticals, Inc. (AcelRx), was approved on November 2, 2018 . This route of administration is intended to be a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage acute pain without difficult intravenous or epidural administration , .
Background
Sufentanil is an opioid analgesic that is used as an adjunct in anesthesia, in balanced anesthesia, and as a primary anesthetic agent. It is administered by the intravenous, epidural and sublingual routes. Also known as Dsuvia, the sublingual form is used for the management of acute pain in adults that is severe to warrant the use of an opioid analgesic in certified medically supervised healthcare settings, including hospitals, surgical centers, and emergency departments . Consideration may be made in the future for the use of the sublingual form in the US military in cases where analgesia is required immediately . The sublingual form, manufactured by AcelRx Pharmaceuticals, Inc. (AcelRx), was approved on November 2, 2018 . This route of administration is intended to be a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage acute pain without difficult intravenous or epidural administration , .
Indication
The indications for this drug are as follows:
Associated Conditions
- Acute Pain
- Severe Acute Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/18 | Phase 4 | Not yet recruiting | YanYing Xiao | ||
2025/06/13 | Phase 4 | Not yet recruiting | University Hospital, Limoges | ||
2025/06/12 | Phase 4 | Not yet recruiting | |||
2025/05/25 | Not Applicable | Recruiting | |||
2025/05/06 | Phase 4 | Not yet recruiting | Qianfoshan Hospital | ||
2025/04/08 | Phase 3 | Recruiting | University Hospital, Clermont-Ferrand | ||
2025/03/25 | Phase 4 | Recruiting | |||
2025/02/05 | Not Applicable | Not yet recruiting | Second Hospital of Shanxi Medical University | ||
2024/08/26 | Early Phase 1 | Not yet recruiting | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | ||
2024/07/31 | Phase 4 | Not yet recruiting | Xiangya Hospital of Central South University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Akorn | 17478-050 | INTRAVENOUS, EPIDURAL | 50 ug in 1 mL | 3/31/2014 | |
| West-Ward Pharmaceuticals Corp. | 0641-6110 | EPIDURAL, INTRAVENOUS | 0.05 mg in 1 mL | 9/17/2018 | |
| West-Ward Pharmaceuticals Corp. | 0641-6111 | EPIDURAL, INTRAVENOUS | 0.05 mg in 1 mL | 9/17/2018 | |
| West-Ward Pharmaceuticals Corp. | 0641-6112 | EPIDURAL, INTRAVENOUS | 0.05 mg in 1 mL | 9/17/2018 | |
| AcelRx Pharmaceuticals, Inc. | 61621-430 | SUBLINGUAL | 30 ug in 1 1 | 12/18/2023 | |
| Hospira, Inc. | 0409-3382 | EPIDURAL, INTRAVENOUS | 50 ug in 1 mL | 7/17/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/25/2018 | ||
Authorised | 6/25/2018 |
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 |
|---|---|---|---|---|---|
| Sufentanil Citrate Injection | 国药准字H20203652 | 化学药品 | 注射剂 | 12/8/2020 | |
| Sufentanil Citrate Injection | 国药准字H20203713 | 化学药品 | 注射剂 | 12/25/2020 | |
| Sufentanil Citrate Injection | 国药准字H20203712 | 化学药品 | 注射剂 | 12/25/2020 | |
| Sufentanil Citrate Injection | 国药准字H20054171 | 化学药品 | 注射剂 | 6/10/2020 | |
| Sufentanil Citrate Injection | 国药准字H20203650 | 化学药品 | 注射剂 | 12/8/2020 | |
| Sufentanil Citrate Injection | 国药准字H20054172 | 化学药品 | 注射剂 | 6/10/2020 | |
| Sufentanil Citrate Injection | 国药准字H20054256 | 化学药品 | 注射剂 | 7/16/2020 | |
| Sufentanil Citrate Injection | 国药准字H20203651 | 化学药品 | 注射剂 | 12/8/2020 | |
| Sufentanil Citrate Injection | 国药准字H20203653 | 化学药品 | 注射剂 | 12/8/2020 | |
| Sufentanil Citrate Injection | 国药准字H20237165 | 化学药品 | 注射剂 | 11/30/2023 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||