Radicava ORS® (edaravone oral suspension) is now available for the treatment of adults with amyotrophic lateral sclerosis (ALS).
Radicava ORS contains the same active ingredient as Radicava, which was originally approved in 2017 as an intravenous (IV) infusion for ALS treatment. The Food and Drug Administration (FDA) approved Radicava ORS in May 2022 based on a bioavailability study, which showed comparable levels of edaravone in the bloodstream with the oral suspension under fasted conditions to that of the IV formulation.
The safety of Radicava ORS was evaluated in 185 patients with ALS in a 24-week, global, open-label phase 3 study (ClinicalTrials.gov Identifier: NCT04165824). Treatment emergent adverse events (TEAEs) reported by at least 5% of patients were muscular weakness (16.2%), fall (15.7%), fatigue (7.6%), back pain (7.0%), constipation (7.0%), headache (5.9%) and dyspnea (5.4%); no serious TEAEs were observed during the study.
The oral suspension can be administered by mouth or via feeding tube using a 5mL oral syringe that comes with the product. Patients treated with the IV infusion may be switched to the oral suspension using the same dosing frequency. Radicava ORS should be taken in the morning on an empty stomach after overnight fasting. Food should not be consumed for 1 hour after administration.
Radicava ORS is supplied as 105mg/5mL of edaravone in a multidose child resistant 60mL bottle. The new oral suspension is available in 2 configurations:
Radicava ORS Starter Kit (14-day treatment cycle), including 2 inner cartons, each containing 1 bottle of 735mg/35mL.Radicava ORS Kit (10-day treatment cycle), including 1 bottle of 1050mg/50mL.
The Company has also created the JourneyMate Support Program to offer educational support and resources for patients receiving ALS treatment.
“Radicava ORS represents an important new treatment option that can be critical in slowing the loss of physical function in ALS,” said Atsushi Fujimoto, President, Mitsubishi Tanabe Pharma America. “I look forward to seeing this orally administered product impact the lives of patients and caregivers.”
Radicava ORS® (edaravone) now available in the US for the treatment of ALS. News release. Mitsubishi Tanabe Pharma America, Inc. Accessed June 15, 2022. https://www.prnewswire.com/news-releases/radicava-ors-edaravone-now-available-in-the-us-for-the-treatment-of-als-301568612.htmlRadicava ORS. Package Insert. Mitsubishi Tanabe Pharma America, Inc.; 2022. https://www.radicava.com/assets/dist/pdfs/radicava-prescribing-information.pdf