ABSTRAL (fentanyl citrate) · SENTYNL THERAPS INC
ABSTRAL is FDA-approved to treat 4 conditions (same as FENTANYL CITRATE PRESERVATIVE FREE).
Details
- Status
- Discontinued
- First Approved
- 2011-01-07
- Routes
- SUBLINGUAL
- Dosage Forms
- TABLET
ABSTRAL Approval History
What ABSTRAL Treats
4 indicationsABSTRAL is approved for 4 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain during anesthesia induction and maintenance
- Postoperative pain in the recovery room
- Supplement to general or regional anesthesia
- Anesthesia for high-risk surgeries (such as open heart, neurological, or orthopedic procedures)
Same approved indications as FENTANYL CITRATE PRESERVATIVE FREE (same active ingredient).
SENTYNL THERAPS INC's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05437575 PAIN | STUDY22010164 HT9425-25-F-0041 | Ph 3 | recruiting | Prehospital Analgesia INtervention Trial (PAIN) |
| NCT06051227 FORE-PAIN | FP-2023 2022-500176-63-00, U1111-1287-7486 | Ph 3 | recruiting | Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial |
| NCT04645823 | Versio4_22112020 2020-005506-26 | Ph 4 | completed | Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor |
| NCT03018756 | DMED-1921-16 | Ph 3 | completed | Nebulized Fentanyl in Patients With Mild to Moderate Interstitial Lung Disease and Chronic Dyspnea |
| NCT03405090 | DMED-1926-16 | Ph 4 | completed | Differential Mechanisms of Dyspnea Relief in Advanced COPD: Opiates vs. Bronchodilators |
| NCT06017141 | STUDY00149314 NCI-2023-05587, IIT-2022-VIVA | Ph 2 | recruiting | Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study |
| NCT03809455 FARADI | UC-0106/1607 SdS 02 FARADI | Ph 2 | withdrawn | Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients |
| NCT01516684 results posted | IRB00017079 NCI-2012-00019, CCCWFU 01211 | Ph 2 | completed | Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures |
| NCT03682211 | SCC01 2011-005161-20, ISRCTN67469672 | Ph 4 | completed | Intranasal Fentanyl Versus Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children |
| NCT01482091 results posted | 11-09-343 | Ph 4 | completed | Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis |
| NCT02576353 | INS002-15-049 | Ph 1 | completed | Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects |
| NCT01308320 | 4-2009-0111 | Ph 4 | completed | Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia |
| NCT00795314 PABADUC | NMU-2008-FY10MZ31 NJFY0811-MZ02 | Ph 4 | completed | Propofol-butorphanol Anesthesia During Uterine Curettage |
| NCT00738192 CARAN | NMU-FY2008-311 NJFY0807311M | Ph 4 | completed | Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia |
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.
ABSTRAL FDA Label Details
Indications & Usage
FDA Label (PDF)ABSTRAL is FDA-approved to treat 4 conditions — same approved indications as FENTANYL CITRATE PRESERVATIVE FREE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.