RADICAVA ORS® (edaravone) oral
FDA approved in 2022
A phase 1 bioequivalence and safety study was conducted in healthy subjects under fasting conditions.1,3
RADICAVA ORS® & RADICAVA® IV
Edaravone for ALS is available in 2 treatment forms:1
RADICAVA® (edaravone) IV
FDA approved in 2017
Actor portrayals.
RADICAVA ORS® gives patients an ORAL option that can fit their life's routines, and offers treatment untethered from IV administration1
RADICAVA® is an FDA-approved treatment shown in a pivotal phase 3 clinical 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® was generally well tolerated in a 6-month phase 3 clinical trial (N=185). In addition to contusion, gait disturbance, and headache reported with RADICAVA®, fatigue was observed in patients receiving RADICAVA ORS®.1,4
Watch the Intro to RADICAVA ORS® video for more about RADICAVA efficacy and safety. Watch Video >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 >RADICAVA ORS® Has Been Evaluated Across 7 Clinical Studies
Pharmacokinetic studies
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
Safety study
A 6-month, phase 3, open-label clinical trial evaluated the safety and tolerability of RADICAVA ORS® in 185 patients with ALS.1
Alternate administration studies
A phase 1 clinical trial evaluated the pharmacokinetics and safety of RADICAVA ORS® administered via PEG tube in patients with ALS.10
A 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 that met its primary endpoint in a phase 3 clinical study.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. Genge A, Pattee GL, Sobue G, et al. Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. Muscle Nerve. 2023;67(2):124-129. 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.
