The Food and Drug Administration (FDA) has approved Radicava ORS® (edaravone) oral suspension 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. Effectiveness was 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 efficacy of Radicava was previously established in a phase 3 study (ClinicalTrials.gov Identifier: NCT01492686), which showed that treatment with Radicava slowed the loss of physical function by 33% compared with placebo at 24 weeks. 

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. 

Loss of physical function was investigated as an exploratory endpoint. Among the 169 patients who complete the study, the average change from baseline in ALS Functional Rating Scale–Revised score was -5.6 (95% CI, -6.5, -4.8).

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 will be available in the coming weeks 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.

References

  1. FDA approves oral form for the treatment of adults with amyotrophic lateral sclerosis (ALS). News release. US Food and Drug Administration. May 12, 2022. Accessed May 13, 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-oral-form-treatment-adults-amyotrophic-lateral-sclerosis-als
  2. Mitsubishi Tanabe Pharma America announces FDA approval of Radicava ORS® (edaravone) for the treatment of ALS. News release. Mitsubishi Tanabe Pharma America, Inc. Accessed May 13, 2022. https://www.multivu.com/players/English/9019751-mitsubishi-tanabe-pharma-america-fda-approval-radicava-ors/
  3. Radicava ORS. Package Insert. Mitsubishi Tanabe Pharma America, Inc.; 2022. https://www.radicava.com/assets/dist/pdfs/radicava-prescribing-information.pdf