CLINICAL STUDIES — No new clinical trials were required for FDA approval of oral edaravone; approval was based on the results of a previous study with IV edaravone and a pharmacokinetic study showing that the bioavailability of a 105-mg dose of the oral suspension is similar to that of a 60-mg IV dose.2

A retrospective cohort study found that use of IV edaravone in patients with ALS was associated with 6 months' longer median overall survival compared to controls.3

An open-label extension study evaluating use of oral edaravone for a total of 3 years' duration is expected to be completed in 2023.

ADVERSE EFFECTS — Adverse effects of edaravone include contusion, gait disturbance, headache, and fatigue. Both the IV and oral formulations contain sodium bisulfite, which can cause hypersensitivity reactions in patients with sulfite allergy.

DOSAGE, ADMINISTRATION, AND COST — Radicava ORS is supplied in 35- and 50-mL bottles containing 105 mg/5 mL of edaravone. The recommended dose is 105 mg administered orally or via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tube in the morning following an overnight fast of at least 8 hours. Patients should not consume any food or drink except water for 1 hour after taking the drug. Edaravone oral suspension should be taken once daily for 14 days, followed by 14 days off for the first cycle; for subsequent cycles, it should be taken once daily for 10 days out of 14, followed by 14 days off.

Four weeks of maintenance treatment with Radicava ORS costs about $12,720; a four-week supply of the IV formulation costs about $12,230.4