RADICAVA ORS® (edaravone) oral
FDA approved in 2022
RADICAVA ORS® (edaravone) oral
FDA approved in 2022
RADICAVA® (edaravone) IV
FDA approved in 2017
Actor portrayals.
RADICAVA® is an FDA-approved treatment shown in a pivotal trial to help slow the loss of physical function in ALS.1,2
RADICAVA ORS® offers the same efficacy as RADICAVA® in an oral formulation.1,3
RADICAVA ORS® safety and tolerability profile was demonstrated in a 6-month clinical trial (N=185).1,4
RADICAVA ORS® should be taken on an empty stomach in the morning after overnight fasting.1 Patients should not consume any food or drink (except water) for 1 hour after administration. For patients who are unable to fast, see full Prescribing Information.
ALS can progress rapidly.5 Beginning treatment with RADICAVA ORS® or RADICAVA® IV can be critical in slowing the loss of physical function.1,2,6
Hear Dr. Appel and Dr. Pattee present data and discuss how RADICAVA ORS® gives patients an administration option that can fit into their life's routines.1
WATCH THE NATIONWIDE WEBCAST VIDEO >A phase 1 bioequivalence and safety study was conducted in healthy subjects under fasting conditions.1,3
Three phase 1 trials evaluated the pharmacokinetics of RADICAVA ORS® (2 trials in healthy subjects and 1 trial in Japanese patients with ALS).7-9
A 6-month, phase 3, open-label clinical trial evaluated the safety and tolerability of RADICAVA ORS® in 185 patients with ALS.1
Phase 1 clinical trial evaluated the pharmacokinetics and safety of RADICAVA ORS® administered via PEG tube in patients with ALS.10
Phase 1, open-label study investigating the safety, tolerability, pharmacokinetics, and bioavailability of RADICAVA ORS® administered orally and via NG tube in healthy subjects.11
Since 1995, RADICAVA® is the only FDA-approved treatment for ALS with positive results from a phase 3 trial despite more than 125 clinical trials from 2008 to 2019.1,2,12,a (see footnote)
aBased on a systematic review of phase II, II/III, and III trials in ALS conducted between 2008 and 2019. Return to content
FDA=Food and Drug Administration.
References: 1. RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 2. Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512. 3. Shimizu H, Nishimura Y, Shiide Y, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197. 4. ClinicalTrials.gov. Safety study of oral edaravone administered in subjects with ALS. Accessed January 31, 2022. https://clinicaltrials.gov/ct2/show/NCT04165824. 5. Grad LI, Rouleau GA, Ravits J, et al. Clinical spectrum of amyotrophic lateral sclerosis (ALS). Cold Spring Harb Perspect Med. 2017;7(8):a024117. 6. Leigh PN, Swash M, Iwasaki Y, et al. Amyotrophic lateral sclerosis: a consensus viewpoint on designing and implementing a clinical trial. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5(2):84-98. 7. ClinicalTrials.gov. Study of oral edaravone in healthy adult males. Accessed January 31, 2022. https://clinicaltrials.gov/ct2/show/NCT04481750. 8. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in patients with amyotrophic lateral sclerosis. Accessed January 31, 2022. https://clinicaltrials.gov/ct2/show/ NCT04176224. 9. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in healthy adult males (drug interaction study and preliminary regimen-finding study). Accessed January 31, 2022. https://clinicaltrials.gov/ct2/show/NCT04481789. 10. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in amyotrophic lateral sclerosis patients with gastrostomy. Accessed January 31, 2022. https://clinicaltrials.gov/ct2/show/NCT04254913. 11. ClinicalTrials.gov. Comparative bioavailability study of oral edaravone administered orally and via a nasogastric tube. Accessed January 25, 2022. https://clinicaltrials.gov/ct2/show/NCT04776135. 12. Wong C, Stavrou M, Elliott E, et al. Clinical trials in amyotrophic lateral sclerosis: a systematic review and perspective. Brain Commun. 2021;3(4): fcab242.
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information.
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information.
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