ALS can progress rapidly.24 Beginning treatment with RADICAVA ORS® can be meaningful in slowing the loss of physical function.2,16,22
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MEDICAL PRACTICE
RADICAVA ORS® recognized as a MAJOR CONTRIBUTION TO PATIENT CARE by the FDA.1 Request a rep visit.
RADICAVA ORS®
RADICAVA ORS® (edaravone) gives patients an ORAL option that can fit their life's routines.2RADICAVA ORS®—the difference is experience
Recognized by the FDA as a major contribution to patient care due to its oral route of administration, offering a less burdensome option vs intravenous administration1
19,300+ people have been treated with RADICAVA formulations since 2017 for
2.5 million+ days of therapy3,a,b (see footnote)
RADICAVA has been prescribed by 2600+ physicians3,a
RADICAVA ORS® is equivalent to the IV formulation of edaravone2,4
RADICAVA® (edaravone) has
been evaluated in over 2 decades of clinical research, including
4 phase 3 trials5-8
RADICAVA formulations have had 7+ years on the market since initial FDA approval in 20172,9
aBased on RADICAVA ORS® and RADICAVA® (edaravone) prescriptions submitted in the US as of May 2025. Not independently verified.
RADICAVA ORS®—built on years of clinical research and development
2024
RADICAVA ORS® recognized as a major contribution to patient care1
- Offering an oral route of administration provides a less burdensome option vs intravenous administration
2022
RADICAVA ORS® approved for ALS9
2021
RADICAVA ORS® submitted for FDA approval10
2019-2021
Pharmacokinetic studies
- A phase 1 bioequivalence and safety study conducted in healthy subjects2,4
- 3 phase 1 trials evaluated the pharmacokinetics of RADICAVA ORS®11-13
Safety study
- A 6-month, phase 3, open-label clinical trial evaluated the safety and tolerability of RADICAVA ORS® in 185 patients with ALS2,6
Alternate administration studies
- A phase 1 clinical trial evaluated the pharmacokinetics and safety of RADICAVA ORS® administered via PEG tube in patients with ALS14
- A phase 1, open-label study investigated the safety, tolerability, pharmacokinetics, and bioavailability of RADICAVA ORS® administered orally and via NG tube in healthy subjects15
2017
RADICAVA® approved for ALS
- The only FDA-approved treatment for ALS that met its primary endpoint in a pivotal phase 3 clinical trial9,16,17
2016
RADICAVA® submitted for FDA approval3
2015
RADICAVA® granted orphan drug status18
2001-2016
Edaravone clinical trials in ALS commence
- A phase 2 study evaluating the efficacy and safety of 2 different concentrations of edaravone5
- 3 phase 3 studies evaluating the efficacy and safety of edaravone in patients with ALS19
Since 1995, RADICAVA is the only FDA-approved treatment for ALS that met its primary endpoint in a phase 3 clinical study.2,16,20,c (see footnote)
In ALS, every point matters21
Losing or keeping a single point on the ALSFRS-R can have a significant impact on those living with ALS. That’s why the pivotal phase 3 clinical trial of RADICAVA® was specifically designed to measure change in physical function assessed by the ALSFRS-R.16,21
For your appropriate patients, initiate treatment with RADICAVA ORS® upon diagnosis22
On average, patients on RADICAVA® lost 2.49 fewer points on the ALSFRS-R vs placebo2,16
RADICAVA was generally well tolerated2
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.2
In the pivotal phase 3 study, the P value was calculated based on the results
It’s important to note a treatment difference of 2.49-point change from baseline in ALSFRS-R (0.99, 3.98) with P=0.0013 is considered statistically significant.16
To put the results in context, consider what P values suggest and how probable the results are due to chance.23
Very strong statistical differenceP<0.001
That means that there is less than 1 in 1000 probability that the results are due to random chance
Statistical differenceP≤0.05
That means that there is less than 5% probability that the results were due to random chance
No statistical differenceP>0.05
No statistical difference
between groups
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.2
WATCH THE NATIONWIDE WEBCAST VIDEO
Request a rep visit for:
- Answers to your questions about RADICAVA ORS®
- Printed copies of the RADICAVA ORS® Built on Solid Ground Clinical History Brochure to share with patients
bDays of therapy based on number of RADICAVA ORS® and RADICAVA® cartons sold as of May 2025. Each carton of RADICAVA® includes 1 day of therapy. For RADICAVA ORS®, each Starter Kit includes 14 days of therapy, and each Maintenance Kit includes 10 days of therapy. Return to content
cBased on a systematic review of phase II, II/III, and III trials in ALS conducted between 2008 and 2019. Return to content
ALSFRS-R=ALS Functional Rating Scale–Revised; BL=baseline; FDA=Food and Drug Administration; IV=intravenous; LS=least squares; NG=nasogastric; PEG=percutaneous endoscopic gastrostomy; SE=standard error.
References: 1. US Food and Drug Administration. Clinical superiority findings. Accessed April 11, 2024. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinicalsuperiority-findings 2. RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 3. Data on file. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc. 4. 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. 5. Yoshino H, Kimura A. Investigation of the therapeutic effects of edaravone, a free radical scavenger, on amyotrophic lateral sclerosis (phase II study). Amyotroph Lateral Scler. 2006;7(4):241-245. 6. ClinicalTrials.gov. Safety study of oral edaravone administered in subjects with ALS. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04165824 7. Brooks BR, Heiman-Patterson T, Wiedau-Pazos M, et al. Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686]. PLoS One. 2022;17(6):e0258614. 8. Takei K, Watanabe K, Yuki S, et al. Edaravone and its clinical development for amyotrophiclateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):5-10. 9. US Food and Drug Administration. FDA approves oral form for the treatment of adults with amyotrophic lateral sclerosis (ALS). Accessed April 11, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-oral-form-treatment-adults-amyotrophic-lateral-sclerosis-als 10. US Food and Drug Administration. NDA 215446. Accessed May 6, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215446Orig1s000ltr.pdf. 11. ClinicalTrials.gov. Study of oral edaravone in healthy adult males. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04481750 12. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in patients with amyotrophic lateral sclerosis. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04176224 13. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in healthy adult males (drug interaction study and preliminary regimen-finding study). Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04481789 14. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in amyotrophic lateral sclerosis patients with gastrostomy. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04254913 15. ClinicalTrials.gov. Comparative bioavailability study of oral edaravone administered orally and via a nasogastric tube. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04776135 16. Writing Group; 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. 17. Tzeplaeff L, Wilfling S, Requardt M, et al. Current state and future directions in the therapy of ALS. Cells. 2023;12(11):1523. 18. US Food and Drug Administration. Orphan drug designations and approvals. Accessed May 15, 2024. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=478215 19. Takei K, Watanabe K, Yuki S, et al. Edaravone and its clinical development for amyotrophiclateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):5-10. 20. 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. 21. Cedarbaum JM, Stambler N, Malta E, et al; BDNF ALS Study Group (Phase III). The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. J Neurol Sci. 1999;169(1-2):13-21. 22. 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. 23. Singh P. P value, statistical significance and clinical significance. J Clin Prev Cardiol. 2013;2(4):202-204. 24. Grad LI, Rouleau GA, Ravits J, et al. Clinical spectrum of amyotrophic lateral sclerosis (ALS). Cold Spring Harb Perspect Med. 2017;7(8):a024117.
