There are a selection of medications which have been approved by the Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS), although there is no cure for the disease.
One of these is Radicava, which is a brand name for a medication known as Edaravone.
Treatments for ALS have been slow in coming and Radicava was the first in 22 years, since Rilutek, to be approved by the FDA for the treatment of ALS.
It is not a cure for the disease and it cannot reverse any damage already caused. However, it has shown to be effective in slowing down the progression of nerve degeneration and extending life expectancy.
Radicava is the brand name of the drug called Edaravone and it works by reducing free radicals. The drug is distributed in the US by MT Pharma America. It currently costs about $1,000 for each infusion and a yearly course of treatment costs $146,000.
Free radicals are produced through the natural processes of our cells while they are making energy. These are normally removed from the body pretty quickly. In certain circumstances, these free radicals can hang around for much longer and can begin to cause oxidative stress. This build-up will damage cells because of the level of toxicity.
This is thought to be a similar process that is seen in ALS, where oxidative stress accumulates and then begins killing off nerve cells. This might be because enzymes that normally get rid of the free radicals are not working properly, in some cases because of a genetic mutation.
In short, the general belief is that Radicava (Edaravone) helps to get rid of free radicals that have accumulated and thus slow down the damage that is done to nerve cells and neurons.
The treatment is different compared to other drugs like Rilutek that are administered in pill form. Radicava is administered on a cyclical basis using an injected infusion.
A patient with ALS will have the drug injected into their bloodstream for 14 days in a row and then there will be a rest period for a couple of weeks. A further infusion is given for 10 out of 14 days before there is another two week period of no treatment.
Each infusion takes about an hour to administer.
As with most drugs, there are side effects associated with Radicava and these have to be taken into account when administering it for any period of time. Side effects include bruising, headaches and skin irritation causing a rash. In more severe circumstances, patients may suffer from respiratory disorders and a deficiency in oxygen.
There can also be problems with gait and difficulty walking. In a few cases, there may be a risk of fungal skin infections. The presence of sodium bisulfate can also cause allergic reactions in some patients.
When it comes to administering Radicava, it’s important to monitor for side effects and ensure that there are no contraindications with other medicines that the patient is taking.
The main piece of research into the effect of Radicava involved 137 individuals who were divided into two groups. The study took place over 6 months where one group was given Radicava and the others was given a placebo.
Measuring increasing disability in ALS patients can be challenging and the standard method is the ALSFRS-R or ALS functional rating scale – revised. Each individual will progress through the disease in their own way. Following the completion of the study, the research found that those in the group receiving Radicava demonstrated 33% less reduction in function compared to those taking the simple placebo.
This study was backed up more recently by a literature review that showed Radicava presented no major adverse problems for patients taking it compared to those having a placebo.
The drug was deemed safe by the FDA in helping to slow down the progression of ALS.