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 studied as adjunctive therapy for partial seizures, a form of epilepsy. It is intended for adults with partial-onset seizures that are not adequately controlled. Supernus Pharmaceuticals is developing it as an extended-release oral treatment in the neurology therapeutic area.
SPN-804 is developed by Supernus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker SUPN. The company is the sponsor of the clinical program evaluating the drug in partial epilepsies.
SPN-804 is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.
SPN-804 has been evaluated in one completed Phase 3 trial, NCT00772603, titled Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures. The randomized, double-blind, placebo-controlled study enrolled 366 adults across the United States, Bulgaria, Canada, Croatia, Mexico, Poland, Romania and Russia.
The Phase 3 trial NCT00772603 was a randomized, double-blind, placebo-controlled study of SPN-804 as adjunctive therapy for partial seizures. It enrolled 366 participants aged 18 years and older of any sex, and it did not use biomarker-based patient selection. The trial has been completed.