Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
USL255 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Open-label USL255 | EXPERIMENTAL | Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day |
| USL255 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| USL255 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Have completed the maintenance period of the P09-004 study. * Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.
USL255 is an investigational small molecule being developed for epilepsy, specifically for patients with refractory partial-onset seizures. It is a Phase 3 candidate studied in adults aged 18 years and older. The drug is not yet approved and remains in clinical development.
USL255 is being developed by Smith & Nephew SNATS, Inc., a company listed on the New York Stock Exchange under the ticker SNN. The developer is responsible for the clinical development of this investigational epilepsy treatment.
USL255 is in Phase 3 clinical development for epilepsy. It has completed two Phase 3 trials, and it is not FDA approved. The drug remains investigational and is not yet available commercially.
USL255 has completed two Phase 3 trials: NCT01142193, a placebo-controlled study of safety and effectiveness in refractory partial-onset seizures with 249 participants, and NCT01191086, an open-label extension safety study with 210 participants. Both trials enrolled adults aged 18 years and older.
No alternative names for USL255 have been disclosed. The drug is identified solely as USL255 in its clinical trials and development program. It is not known to be marketed under any other name.