Phase 3, Open-Label, Safety Extension Study of Oral Edaravone (Radicava ORS®) Administered Over 96 Weeks in Patients with ALS (MT-1186-A03)
Angela Genge1, Gary Pattee2, Gen Sobue3, Masashi Aoki4, Hiide Yoshino5, Philippe Couratier6, Christian Lunetta7, Susanne Petri8, Daniel Selness9, Vesna Todorovic10, Manabu Hirai11, Alejandro Salah9, Stephen Apple9, Art Wamil9, Alexander Kalin9, Carlayne A. Jackson12
1Montreal Neurological Institute and Hospital, 2University of Nebraska Medical Center, 3Nagoya University Graduate School of Medicine, Aichi Medical University, 4Tohoku University School of Medicine, 5Neurology Clinic, 6CRMR SLA Service de Neurologie, CHU de Limoges, 7Istituti Clinici Scientifici Maugeri IRCCS, Neurorehabilitation Unit of Milano, 8Hannover Medical School, 9Mitsubishi Tanabe Pharma America, Inc., 10Mitsubishi Tanabe Pharma Europe Ltd., 11Mitsubishi Tanabe Pharma Corporation, 12University of Texas Health Science Center at San Antonio
Objective:
To evaluate the safety of Radicava ORS® (edaravone) oral suspension (Mitsubishi Tanabe Pharma America [MTPA], hereafter “MTPA oral edaravone”) in patients with amyotrophic lateral sclerosis (ALS) over 96 weeks.
Background:
Radicava® (edaravone) IV (intravenous; MTPA, hereafter “MTPA IV edaravone”) and MTPA oral edaravone were approved by the US Food and Drug Administration (FDA) for the treatment of ALS in 2017 and 2022, respectively, and studies have demonstrated these approved formulations have similar pharmacokinetics. Study MT-1186-A01 indicated that MTPA oral edaravone was well-tolerated over 48 weeks, with no new safety concerns identified.
Design/Methods:
Study MT-1186-A03 (NCT04577404) was a phase 3, open-label, multi-center, extension study that evaluated the long-term safety of MTPA oral edaravone over an additional 96 weeks in patients who have completed the initial 48 weeks of Study MT-1186-A01. Participants received MTPA oral edaravone (105-mg dose) according to the FDA-approved dosing for MTPA IV edaravone. Upon entering Study MT-1186-A01, patients had definite, probable, probable-laboratory-supported, or possible ALS; baseline forced vital capacity ≥70%; and baseline disease duration ≤3 years.
Results:
In Study MT-1186-A03, MTPA oral edaravone was well tolerated with no new safety concerns. The most common treatment-emergent adverse events (TEAEs) were fall, muscular weakness, dyspnea, constipation, and dysphagia. These TEAEs were consistent with the safety profile for MTPA edaravone from previous clinical trials.
Conclusions:
MTPA oral edaravone showed no new safety concerns and was well-tolerated during the 96-week study period of MT-1186-A03, for a total of 144 weeks when including Study MT-1186-A01.
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