Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tramadol · 3 trials · 1 indication
Reported Adverse Events
Pain intensity was recorded using the Numerical Pain Rating Scale (NPRS) from 0 to 10, where 0 was no pain and 10 was the worst pain imaginable at hrs: .5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48. As higher pain scores indicate worse pain, a negative Pain Intensity Difference (PID) indicates less pain (improvement from baseline). Thus, SPID scores are expected to be negative if a patient's pain decreases over time, with the lower SPID values indicating greater reduction in pain intensity.
| Arm | Type | Description |
|---|---|---|
| Tramadol 50 mg | ACTIVE_COMPARATOR | Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
| Morphine 4 mg | ACTIVE_COMPARATOR | Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
| Placebo | PLACEBO_COMPARATOR | Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
| AVE-901 50mg | OTHER | IV Tramadol |
| AVE-901 50 mg | ACTIVE_COMPARATOR | - |
| AVE-901 25 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tramadol | DRUG | IV Tramadol 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
| Morphine | DRUG | Morphine 4 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
| Placebo | OTHER | Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
Inclusion Criteria: * The patient is male or female 18-75 years of age * Willing to give consent and able to understand the study procedures * Female patients must be of non-childbearing potential or be practicing a highly effective contraption * The patient must be willing to be housed in a health...
Top 2 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viking Therapeutics, Inc. | VKTX | 4 | PHASE3 | VK2735 |
| Structure Therapeutics, Inc. Sponsored ADR | GPCR | 1 | PHASE2 | Aleniglipron |
Tramadol is being developed for pain management, specifically the treatment of postoperative pain. The clinical program includes studies in pain following abdominoplasty, bunionectomy, and general surgery. It is a small molecule therapeutic candidate under development by Fortress Biotech, Inc. for patients requiring pain relief after surgical procedures.
Tramadol targets OPRM1, the mu-opioid receptor. It acts as an agonist at this receptor, meaning it binds to and activates the receptor to produce analgesic effects. This mechanism underlies its development for pain management, including postoperative pain following surgical procedures.
Tramadol is being developed by Fortress Biotech, Inc., which trades under the ticker symbol FBIO. The company is advancing the small molecule candidate for pain management, with a clinical program that includes Phase 3 trials in postoperative pain settings.
Tramadol is in Phase 3 clinical development for pain management. It is an investigational therapy and has not been approved by the FDA for the studied postoperative pain indications. The Phase 3 program includes both active and completed trials evaluating its use in surgical pain settings.
Tramadol has been studied in three Phase 3 clinical trials. NCT03774836 is an active trial comparing Tramadol with placebo and morphine for post-operative pain after abdominoplasty. NCT03395808 evaluated safety in postoperative pain following surgery, and NCT03290378 compared Tramadol with placebo after bunionectomy. Total enrollment across these trials is 1,020 participants.