Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
tapentadol Immediate Release IR · 1 trial · 1 indication
For this twice daily pain assessment, the subjects were to indicate the level of average pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | tapentadol (CG5503) Immediate Release (IR) Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100 150 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second,tapentadol (CG5503) Immediate Release IR 21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period |
| 002 | EXPERIMENTAL | tapentadol (CG5503) Extended Release (ER) During 2 double blind periods: Tapentadol ER 100 150 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second |
| Name | Type | Description |
|---|---|---|
| tapentadol (CG5503) Immediate Release IR | DRUG | 21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period |
| tapentadol (CG5503) Extended Release (ER) | DRUG | During 2 double blind periods: Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second |
| tapentadol (CG5503) Immediate Release (IR) | DRUG | Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second |
Inclusion Criteria: * Diagnosis of Low Back Pain (LBP) of non-malignant origin present for at least 3 months immediately before study entry * Taking drug treatment for pain for at least 3 months before screening and who are dissatisfied with current therapy * Subjects receiving opioid treatment mus...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Hinge Health, Inc. Class A | HNGE | 1 | N/A | Undisclosed |
| Stryker Corporation | SYK | 1 | - | Undisclosed |
| Boston Scientific Corporation | BSX | 1 | N/A | Undisclosed |
| Aclarion, Inc. | ACON | 1 | - | Undisclosed |
| United Therapeutics Corporation | UTHR | 1 | N/A | Undisclosed |
| eHealth, Inc. | EHTH | 1 | N/A | Undisclosed |
Tapentadol Immediate Release (IR) is an investigational small molecule being studied for the treatment of chronic low back pain. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being evaluated for its safety and effectiveness in patients with this condition.
Tapentadol Immediate Release (IR) is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 3 clinical trials for the treatment of chronic low back pain.
Tapentadol Immediate Release (IR) is in Phase 3 clinical development. It is an investigational drug being studied for chronic low back pain and is not yet approved by the FDA. The Phase 3 trial has been completed, with results expected to inform further development.
Tapentadol Immediate Release (IR) has one completed Phase 3 clinical trial, identified as NCT00594516. This study, titled 'Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain,' enrolled 117 participants and was a randomized, double-blind, controlled trial.
Tapentadol Immediate Release (IR) is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for chronic low back pain. The drug has completed a Phase 3 trial, but approval status has not been established, and it remains under investigation.