RADICAVA ORS® recognized as a MAJOR CONTRIBUTION TO PATIENT CARE by the FDA.1 Request a rep visit.
Learn about the ALS Functional Rating Scale-Revised (ALSFRS-R) for evaluating the decline in physical function over time.
 | RADICAVA® (edaravone) has been evaluated in over two decades of clinical research, including four phase 3 trials2-5 |
The ALSFRS-R is a validated, questionnaire-based tool for evaluating decline in physical function over time.7,8
Tap on each item below to see the point descriptions.
SPEECH:
SALIVATION:
SWALLOWING:
Cutting Food (Patients without gastrostomy)Cutting Food (Patients with gastrostomy)Dressing and Hygiene 
Handwriting:
CUTTING FOOD:
(without gastrostomy)
CUTTING FOOD:
(with gastrostomy)
Dressing and Hygiene:
TURNING IN BED:
WALKING:
CLIMBING STAIRS:
DYSPNEA:
ORTHOPNEA:
Respiratory Insufficiency:
Consider what a 1-point loss may mean for7,9:
Dietary consistency changes
Needs supplemental tube feeding
Needs attendant
for self-care
Total dependence
Early ambulation difficulties
Walks with assistance
Intermittent use
of BiPAP
Continuous use
of BiPAP
The ALSFRS-R was used to assess the primary endpoint in the pivotal phase 3 clinical trial for RADICAVA®.11,a (see footnote)
ALSFRS-R=ALS Functional Rating Scale-Revised; BiPAP=bilevel positive airway pressure; IV=intravenous.
aMean change in ALSFRS-R at 24 weeks.12 Return to content
In the evaluation of physical function, the higher the score, the greater the physical function7,9
See how RADICAVA® was proven to slow the loss of physical function in patients with ALS.
Based on data from the PRO-ACT database, the average rate of ALSFRS-R decline is 1.02 points/month.13
Due to the heterogeneity of ALS, individual decline on the ALSFRS-R may vary widely among patients, with some patients losing 0 to 1 point per month and others losing up to 6 points per month.14
A 20% to 25% or greater change in the slope of ALSFRS-R, reflecting the slowing of functional decline, is considered clinically meaningful by the Northeast ALS Consortium (NEALS), based on a report surveying 65 of its members.10
Losing or keeping a single point on the ALSFRS-R can have a significant impact on those living with ALS.4
ALS can progress rapidly.8 Beginning treatment with RADICAVA ORS® (edaravone) can be meaningful in slowing the loss of physical function.15,16
BiPAP=bilevel positive airway pressure; FDA=Food and Drug Administration; PRO-ACT=Pooled Resource Open-Access ALS Clinical Trials.
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/clinical-superiority-findings 2. 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. 3. ClinicalTrials.gov. Safety study of oral edaravone administered in subjects with ALS. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04165824 4. 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. 5. Takei K, Watanabe K, Yuki S, et al. Edaravone and its clinical development for amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):5-10. 6. Eisen A. Motor neurone disease. In: Turner MR, Kiernan MC, eds. Landmark Papers in Neurology. Oxford University Press; 2015:257-288. 7. 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. 8. 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. 9. The ALS C.A.R.E. Program. Center for Outcomes Research, University of Massachusetts Medical School. ALS functional rating scale. Accessed January 6, 2022. http://www.outcomes-umassmed.org/ALS/alsscale.aspx. 10. Castrillo-Viguera C, Grasso DL, Simpson E, et al. Clinical significance in the change of decline in ALSFRS-R. Amyotroph Lateral Scler. 2010;11(1-2):178-180. 11. Mitsumoto H, Brooks BR, Silani V. Clinical trials in amyotrophic lateral sclerosis: why so many negative trials and how can trials be improved? Lancet Neurol. 2014;13:1127-1138. 12. Su XW, Broach JR, Connor JR, et al. Genetic heterogeneity of amyotrophic lateral sclerosis: implications for clinical practice and research. Muscle Nerve. 2014;49:786-803. 13. Atassi N, Berry J, Shui A, et al. The PRO-ACT database: design, initial analyses, and predictive futures. Neurology. 2014;83:1719-1725. 14. Proudfoot M, Jones A, Talbot K, et al. The ALSFRS as an outcome measure in therapeutic trials and its relationship to symptom onset. Amyotroph Lateral Scler Frontotemporal Degener. 2016;17(5-6):414-425. 15. 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. Samadhiya S, Sardana V, Bhushan B, et al. Assessment of therapeutic response of edaravone and riluzole combination therapy in amyotrophic lateral sclerosis patients. Ann Indian Acad Neurol. 2022;25(4):692-697
RADICAVA ORS® (edaravone) is 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.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
RADICAVA ORS contains 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® (edaravone)-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.
Based on animal data, 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 ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information also available www.radicavaors.com.
RADICAVA ORS® (edaravone) is 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.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
RADICAVA ORS contains 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® (edaravone)-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.
Based on animal data, 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 ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information also available www.radicavaors.com.
RADICAVA, RADICAVA ORS, the RADICAVA ORS logo, and the corporate symbol of Mitsubishi Tanabe Pharma America are registered trademarks of Mitsubishi Tanabe Pharma Corporation.
JourneyMate Support Program is a trademark of Mitsubishi Tanabe Pharma America, Inc.
All other company names, product names, trade/service marks or other trade names are the property of their respective owners.
For US Healthcare Professionals Only.
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