Edaravone, whose brand name is Radicava, is the first U.S.-approved treatment for amyotrophic lateral sclerosis (ALS) in more than 20 years.
Mitsubishi Tanabe Pharma Corporation developed the intravenous therapy, which slows the decline in ALS patients’ physical functioning. MT Pharma America is marketing the treatment in the United States. The drug was once known as MCI-186.
Edaravone (Radicava) research
A Phase 3 study (NCT00330681) evaluated the effectiveness and safety of edaravone in treating ALS. After a 12-week observation period, the 137 participants were divided into two groups. One received 60 mg of edaravone intravenously on a specified schedule and the other a placebo, both for six months.
The primary objective of the study was for the treatment group to improve their score in a measurement of disability progression known as the ALS Functional Rating Scale-Revised (ALSFRS-R) scale. Although the rate of progression varies between patients, research has shown that people with ALS lose an average of one point per month on this scale.
After six months of treatment, those who received edaravone (Radicava) experienced a 33% decline in the progression of their disability, compared with the placebo group. That figure was considered statistically significant.
The most common adverse reactions to the treatment were walking problems, bruises and headaches.
Edaravone (Radicava) is administered intravenously in 28-day cycles. The treatment starts with a patient receiving the therapy for 14 consecutive days, followed by a two-week drug-free period. Patients then receive an infusion during 10 of the next 14 days, followed by a two-week drug-free period.
Patients are prescribed 60 mg per treatment, and each treatment takes 60 minutes.
It is important that patients make their healthcare provider aware of other medical conditions they have that could lead to complications, including asthma and allergies to other medicines. They also should let their provider know if they are pregnant, or plan to become pregnant, or if they are breastfeeding or plan to breastfeed.
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