Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-954561 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 BMS-954561 40mg or 80mg | OTHER | Arm description: BMS-954561 40mg or 80mg three times daily (TID) to Placebo OR Placebo to 40mg or 80mg TID. Arm type: Active to Placebo or Placebo to Active (cross-over) |
| Arm 2 BMS-954561 150mg or 300mg | OTHER | Arm description: BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Arm type: Active to Placebo or Placebo to Active(cross-over) |
| Arm 1: BMS-954561 40mg or 80mg | OTHER | BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over) |
| Arm 2: BMS-954561 150mg or 300mg | OTHER | BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over) |
| Arm 3: Pregabalin 100mg | OTHER | Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over) |
| Name | Type | Description |
|---|---|---|
| BMS-954561 | DRUG | - |
| Placebo | DRUG | - |
| Pregabalin | DRUG | - |
| Placebo matching BMS-954561 | DRUG | - |
| Placebo matching Pregabalin | DRUG | - |
Inclusion Criteria: * Patient with Post-Herpetic Neuralgia (PHN) as defined as pain present for more than 6 months after the onset of a herpes zoster skin rash affecting the trigeminal, cervical, thoracic, lumbar, or sacral regions. * Based on patient diary information collected during the Baseline...
BMS-954561 is an investigational small molecule being developed for the treatment of diabetic peripheral neuropathic pain and post-herpetic neuralgia (PHN). It is currently in Phase 2 clinical development for these neuropathic pain conditions.
BMS-954561 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY.
BMS-954561 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 clinical trials for the drug have been completed.
BMS-954561 has been studied in two completed Phase 2 clinical trials. NCT01305538 enrolled 100 participants with post-herpetic neuralgia, and NCT01314222 enrolled 178 participants with diabetic peripheral neuropathic pain. Both trials were conducted in the United States and France.
BMS-954561 is the primary name for this investigational compound. No alternative names have been reported for this drug in clinical development.