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edaravone (Radicava)

Indications: - treatment of amyotrophic lateral sclerosis (ALS) - may benefit mildly symptomatic patients (probably not) [3] Contraindications: - hypersensitivity to sulfite - no disease-modifying benefit for patients with ALS [3] Dosage: - intravenous infusion - initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period - subsequently dosing on 10 of 14 days, followed by a 14 day drug-free period Adverse effects: - most common: bruising, gait disturbance Mechanism of action: - unknown, free radical scavenger - may lessen effects of oxidative stress Notes: - contains sodium bisulfite - orphan drug designation - potentially high price tag, despite generic versions available in China & India

General

neurologic agent antioxidant aromatic compound heterocyclic compound, 1 ring

Database Correlations

PUBCHEM cid=4021

References

  1. Fiore K FDA Okays Antioxidant Drug for ALS - Drug may work best in patients with preserved function. MedPage Today. May 5, 2017 https://www.medpagetoday.com/Neurology/GeneralNeurology/65087 - FDA News Release. May 5, 2017 FDA approves drug to treat ALS https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm - Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  2. Tanaka M, et al. A 24-Week, Phase III, Double-Blind, Parallel-Group Study of Edaravone (MCI-186) for Treatment of Amyotrophic Lateral Sclerosis (ALS) (P3.189). American Academy of Neurology Annual Meeting. Vancouver, BC. 2016 Apr 18.
  3. George J Does Edaravone Slow ALS Progression? Even in subgroup with expected efficacy, prospective study finds no significant effect. MedPage Today January 10, 2022 https://www.medpagetoday.com/neurology/generalneurology/96576 - Witzel S, Maier A, Steinbach R et al Safety and Effectiveness of Long-term Intravenous Administration of Edaravone for Treatment of Patients With Amyotrophic Lateral Sclerosis. JAMA Neurol. Published online January 10, 2022 PMID: 35006266 https://jamanetwork.com/journals/jamaneurology/fullarticle/2787473