RADICAVA ORS® recognized as a MAJOR CONTRIBUTION TO PATIENT CARE by the FDA.1 Request a rep visit.
RADICAVA ORS® (edaravone)
has the same efficacy as RADICAVA® (edaravone).2
 | RADICAVA ORS® is 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 |
Results from a phase 1 pharmacokinetic study in healthy subjects under fasted conditions showed equivalent plasma levels with RADICAVA ORS® and RADICAVA®.5
The pivotal phase 3 clinical trial was specifically designed to measure change in physical function assessed by the ALSFRS-R4,6,7
At randomization4
Deterioration in ALSFRS-R score of 1 to 4 points during 12-week pre-study observation period
Used a defined population based on an analysis of an earlier clinical trial
Identified patients who would be expected to have a sufficient and measurable deterioration over 24 weeks in order to see a treatment effect
Physical Function in Daily Activities at 24 Weeks2,4
Over 90% of patients in each group were also being treated with riluzole.4,8
RADICAVA slowed the loss of physical function by 33% compared to placebo at 24 weeks, as measured by the ALSFRS-R.2
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
That means that there is less than 1 in 1000 probability that the results are due to random chance
That means that there is less than 5% probability that the results were due to random chance
No statistical difference
between groups
Physical Function in Daily Activities at 24 Weeks4,8
91.3%
RADICAVA®
(n=63/69)
91.2%
Placebo
(n=62/68)
In the phase 3 clinical trial, RADICAVA® was shown to slow the decline of physical function in patients with ALS.2
“…the overall distribution shift suggests that the effect of slowing decline…was driven by the majority of patients responding to treatment rather than a response to treatment that was limited to a specific subtype of patient.”10
ALS can progress rapidly.11 Beginning treatment with RADICAVA ORS® can be critical in slowing the loss of physical function.4,12
RADICAVA ORS®—the ONLY FDA-approved oral form of edaravone—was built on years of clinical research and development
aJapan ALS severity classification grades, which were used for the pivotal clinical trial (J19), range from 1 to 5 as follows9:
1. Able to work or perform housework. 2. Independent living but unable to work. 3. Requiring assistance for eating, excretion, or ambulation. 4. Presence of respiratory insufficiency, difficulty in coughing out sputum, or dysphagia. 5. Using a tracheostomy tube, tube feeding, or tracheostomy positive-pressure ventilation. Return to content
ADL=activities of daily living; BL=baseline; FVC=forced vital capacity; LS=least squares; QD=once daily; 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. 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. 4. 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 Jul;16(7):505-512. 5. 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. 6. Takei K, Tsuda K, Takahashi F, et al. Post-hoc analysis of open-label extension period of study MCI186-19 in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):64-70. 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. Data on file. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc. 9. Singh P. P value, statistical significance and clinical significance. J Clin Prev Cardiol. 2013;2(4):202-204. 10. Takei K, Takahashi F, Liu S, et al. Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):49-54. 11. Sawada H. Considerations for pharmacotherapy use in patients with amyotrophic lateral sclerosis: the earlier it starts, the better the results. Expert Opin Pharmacother. 2019;20(14):1671-1674. 12. 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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