Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPN-804 · 1 trial · 1 indication
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH\[T\]), Intent-to-Treat population.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo - four identical tablets taken orally once daily |
| 2400 mg SPN-804 | ACTIVE_COMPARATOR | 2400mg OXC XR taken orally once daily as four identical tablets |
| 1200mg SPN-804 | ACTIVE_COMPARATOR | 1200mg OXC XR taken orally once daily as four identical tablets |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Non-active tablet identical to study drug tablets |
| 2400mg SPN-804 | DRUG | tablets containing 600mg OXC XR, identical to non-active tablets |
| 1200mg SPN-804 | DRUG | two active tablets and two non-active tablets, all identical |
Inclusion Criteria: * Capable of complying with the study procedures. * Able to provide written informed consent * Male or female aged 18 to 65 years, inclusive. * Diagnosis of partial onset seizures * Minimum of three seizures per 28 days * Receiving treatment with 1-3 AEDs * Refractory to at leas...
SPN-804 is an investigational small molecule being developed for the treatment of partial epilepsies, also known as partial seizures. It is intended as an adjunctive therapy, meaning it is added to other antiseizure medications to help control seizures in patients with this condition.
SPN-804 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its ability to reduce the frequency of partial seizures when used alongside other antiseizure treatments.
SPN-804 is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with partial epilepsies.
SPN-804 is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not been approved by regulatory authorities.
SPN-804 has been studied in one completed Phase 3 clinical trial, identified as NCT00772603. This trial evaluated the efficacy and safety of SPN-804 as an adjunctive therapy for partial seizures in 366 adult patients across multiple countries, including the United States, Bulgaria, Canada, Croatia, Mexico, Poland, Romania, and Russia.
SPN-804 is the same as OXC XR, as indicated by the clinical trial title. The Phase 3 study NCT00772603 evaluated the efficacy and safety of OXC XR, which is the extended-release formulation being developed under the name SPN-804 for partial seizures.