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 diabetic peripheral neuropathic pain and post-herpetic neuralgia (PHN). It is in Phase 2 clinical development and is not approved by the FDA.
BMS-954561 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY.
BMS-954561 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA.
BMS-954561 has completed two Phase 2 trials. NCT01305538 studied the drug in post-herpetic neuralgia with 100 participants, and NCT01314222 studied it in diabetic peripheral neuropathic pain with 178 participants. Both trials were conducted in the United States and France.
No alternative names for BMS-954561 have been disclosed. It is referred to solely by its development code.