To provide updated pharmacokinetic (PK) data for a potential new oral suspension formulation of edaravone and describe its anticipated planned development.

A Phase 1, oral, dose-ranging PK study was conducted in healthy volunteers.

Preliminary results indicated that C_max and AUC increased with dose increases up to 300 mg. A single oral dose of approximately 100 mg of edaravone is expected to have similar C_max and AUC as observed with the 60 mg/60 min IV infusion. No new safety findings were noted following single doses of up to 300 mg of oral edaravone relative to IV infusion. Significant reductions in C_max and AUC occurred when oral edaravone was administered with food.

The clinical development plan for the oral suspension is ongoing and may be revised based on the results. Proposed studies include a PK bridging strategy (to expedite the development of the oral formulation), a pivotal cross-over study demonstrating equivalent PK between the oral and IV formulations, an open-label safety study in patients with ALS, and a study to investigate 3 different regimens for the oral formulation: an oral 2-week on/off cycle, a daily oral dosing at the equivalent IV dose, and a daily “high-dose” treatment.