Radicava ORS demonstrates long-term safety, tolerability in patients with ALS

Results from a phase 3 clinical trial showed that Radicava ORS was safe in and well-tolerated by patients with ALS after 48 weeks of treatment, according to a manufacturer press release.

The findings support last year’s FDA approval of Radicava ORS oral suspension (edaravone, Mitsubishi Tanabe Pharma America), which were based on study findings at 24 weeks.

“We’re encouraged by the data that we continue to collect from the global phase 3 trial of Radicava ORS, demonstrating a favorable safety profile after 48 weeks of treatment,” Gustavo A. Suarez Zambrano, MD, vice president of medical affairs at Mitsubishi Tanabe Pharma America, said in the release.

The trial enrolled 185 patients in the United States, Canada, Europe and Japan, with 25% discontinuing use of edaravone before the end of the study. According to the release, the most common treatment-emergent adverse events were fall (22.2%), muscular weakness (21.1%), constipation (17.8%), dyspnea (10.8%), dysphagia (10.3%) and back pain (10.3%), with no serious adverse events reported. However, there were 12 deaths related to treatment-emergent adverse events, none of which were deemed to be associated with the use of edaravone.

“Our hope is for these data to provide additional information to physicians who are considering this oral treatment option for their patients,” Gary L. Pattee, MD, a neurologist and ALS specialist in Lincoln, Nebraska, said in the release.