The intravenous formulation of RADICAVA® is no longer available. If you are interested in the oral formulation, RADICAVA ORS®, talk to your doctor to see if it’s right for you.
FDA recognizes RADICAVA ORS® as MAJOR CONTRIBUTION TO PATIENT CARE Call a JourneyMate Resource Specialist at 1-855-457-6968.
FDA recognizes RADICAVA ORS® as MAJOR CONTRIBUTION TO PATIENT CARE Call a JourneyMate Resource Specialist at 1-855-457-6968.
Why RADICAVA ORS® for ALS?
RADICAVA ORS® (edaravone) is an ORAL administration option of RADICAVA® (edaravone) IV, an ALS treatment shown to slow the loss of physical function.
In 2024, FDA recognized RADICAVA ORS® as a major contribution to patient care
It provides a clinically superior option for patients—due to its oral suspension route of administration that provides a less burdensome option vs intravenous administration.
From 2019 to March 2024, RADICAVA ORS® is 1 of 4 medications given this recognition.
Learn more about
How to Take RADICAVA ORS®
Have questions as you learn about RADICAVA ORS®?
Call a JourneyMate Resource Specialist at 1-855-457-6968
between 9 AM and 9 PM ET, Monday through Friday.
RADICAVA ORS® Is Built on Solid Ground
RADICAVA ORS® was recognized by the FDA in 2024 for its major contribution to patient care
17,400+ people have been
treated with RADICAVA since
2017 for 2.2 million+ days of
therapya,b (see footnote)
RADICAVA ORS® was
FDA-approved in 2022 and
offers the same drug as
RADICAVA® IV in an oral
formulation
RADICAVA formulations have had 7+ years on
the market since initial FDA approval in 2017
The safety and tolerability of
RADICAVA has been studied in
500+ people across multiple clinical
studies since 2017
RADICAVA has been evaluated
in over 2 decades of clinical
research, with efficacy
demonstrated in a pivotal
phase 3 clinical trial
Learn more about how RADICAVA ORS® was built on a foundation of data.
Watch now
aBased on RADICAVA ORS® and RADICAVA® IV prescriptions submitted in the US as of December 2024. Not independently verified.
RADICAVA ORS® —A Foundation of Clinical and Real-World Experience
In ALS, every point matters
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.
In the clinical study, RADICAVA® showed a statistically significant change in physical function measured by the ALSFRS-R compared to those not taking RADICAVA® at 24 weeks
RADICAVA® slowed the loss of physical function at 24 weeks (about 6 months), where patients who did not receive RADICAVA® declined more rapidly in physical function, having lost an average of 2.49 points more.
RADICAVA ORS® is an oral form of RADICAVA® IV
RADICAVA® resulted in a 33% less decline in physical function vs placebo (P=0.0013). A change in the ALSFRS-R of 20% to 25% or greater is considered clinically meaningful according to the Northeast ALS Consortium (NEALS).
Researchers determined that RADICAVA® outperformed placebo (a treatment that contains no actual medicine) significantly. This was indicated by using a “P value,” a statistical form of measurement.
P value indicates how probable the results are due to chance
P<0.001
Very strong statistical evidenceMeaning there is less than a 1 in 1000 probability that the results are due to random chance
P≤0.05
Statistical differenceMeaning there is less than 5% probability that the results are due to random chance
P>0.05
No statistical differenceMeaning no statistical difference between groups
Over 90% of patients in each group were also being treated with riluzole.
RADICAVA ORS® is Generally Well Tolerated
RADICAVA ORS® is the oral formulation of RADICAVA® IV and has a similar safety profile.
The safety profile of RADICAVA was established in 500+ patients with ALS in multiple clinical studies.
Side effect profile:
The safety of RADICAVA® IV was evaluated in multiple placebo-controlled studies in 184 patients with ALS
RADICAVA ORS® was generally well tolerated in a 6-month clinical study of 185 patients with ALS
The most common side effects of RADICAVA® (edaravone) and RADICAVA ORS include bruising (contusion), problems walking (gait disturbance), and headache.
These are not all of the possible side effects of RADICAVA and RADICAVA ORS.
RADICAVA ORS® and RADICAVA® IV have no known drug interactions
Fewer than 6% (11/185) of patients discontinued RADICAVA ORS® because of side effects in the 6-month safety study in 185 patients with ALS
Approximately 1% (2/185) of patients discontinued RADICAVA ORS® due to gastrointestinal side effects (diarrhea and trouble swallowing)
Other reasons for discontinuation in ~1% (2/185) of patients included respiratory failure and muscular weakness
Other considerations
RADICAVA ORS® and RADICAVA® IV have been used in clinical studies with other approved drugs for ALS, including riluzole
Be sure to tell your doctor if you are allergic to other medications and share all of the medications you are taking
The Prescribing Information has no requirement for monitoring kidney or liver function.
RADICAVA ORS® may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.
Make sure to tell your doctor:
If you have asthma
If you are allergic to other medications
If you are pregnant or intend to become pregnant
If you are breastfeeding or intend to breastfeed
All of the medications you are taking
Please see additional Important Safety Information.
RADICAVA ORS® is Formulated to Fit Your Life’s Routines
Can be taken orally or via feeding tube
5 mL dose may only take a few minutes to administer on treatment days c (see footnote)
After the initial starter dose, only dosed 10 out of 14 days, followed by a 14-day drug-free period – to allow for more treatment-free days
After we talked more about RADICAVA ORS®, my neurologist and I decided it was the right move for me. Now that I’ve been taking RADICAVA ORS®, I can say it really fits into my life’s routines.
How RADICAVA ORS® May Help
Watch this video explaining how RADICAVA ORS® was shown to treat people with ALS.
When it came to RADICAVA, I extensively researched any information available and had in-depth discussions with my neurologist and we decided it was the right choice for me.
RADICAVA ORS® Is Built on Solid Ground
Get your copy of a handy resource that provides an overview of the RADICAVA ORS® history of clinical and real-world experience, including:
- Why every ALSFRS-R point matters
- RADICAVA ORS® efficacy and safety information
- How it’s formulated to fit your life’s routines
Understanding Your Treatment With RADICAVA ORS®
Watch this video to learn more about this oral ALS treatment option.
You can also see a Clinical Educator share important information in this video:
Starting Treatment With RADICAVA ORS®
bDays of therapy based on number of RADICAVA ORS® and RADICAVA® IV cartons sold as of December 2024. Each carton of RADICAVA® IV 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
cUse the provided 5 mL syringe that comes with the product. Do not use a household teaspoon to measure your medication. Return to content
ALSFRS-R=ALS Functional Rating Scale–Revised; FDA=Food and Drug Administration; IV=intravenous.
