New ALS Drug Relyvrio (AMX0035) Approved by FDA
On Sept. 29, the U.S. Food and Drug Administration (FDA) approved AMX0035, a new ALS drug that will be marketed in the United States under the name RELYVRIO. Phase 2 clinical trial results from 2020 indicate that this new drug can slow ALS functional decline in a meaningful way. Learn more on our new RELYVRIO page.
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Rilutek® (riluzole)
Studies have shown that riluzole, approved by the U.S. Food and Drug Administration (FDA) in 1995, can extend the life of ALS patients for a few months, particularly if you begin taking it shortly after diagnosis.
Side effects are rare, but can include dizziness, nausea, weakness, drowsiness, stomach pain, and vomiting. Some people cannot tolerate it. Medicare, Medicaid, the VA, and many private insurance policies cover it. |
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If you decide to take riluzole, discuss with your ALS clinic team. For the first few months, you may need to have blood drawn to monitor your liver function enzymes.
If you have trouble swallowing pills, the FDA approved a liquid form of riluzole called Tiglutik in 2018.
If you have trouble swallowing pills, the FDA approved a liquid form of riluzole called Tiglutik in 2018.

Radicava® (edaravone)
In 2017, the FDA approved Radicava to treat ALS after one six-month clinical trial in Japan in which the drug maker claimed that Radicava slowed the decline of physical function by 33%.
Since Radicava’s release, there have been no other clinical trials. Some studies and reviews have highlighted its benefits, though others have questioned its effectiveness. Benefits may be more likely if you begin early in your disease progression.
Radicava was administered through intravenous infusions (IVs) until the oral formulation, Radicava ORS, was approved by the FDA in May 2022. The FDA writes: “Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral medication has the same dosing regimen as Radicava—an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.”
Regarding side effects, the FDA writes: “The most common side effects of Radicava are bruising (contusions), problems walking (gait disturbances), and headaches. Fatigue is also a possible side effect from Radicava ORS. Radicava and Radicava ORS can have serious side effects associated with allergic reactions including hives, rash, and shortness of breath. For patients with sulfite sensitivity, sodium bisulfite—an ingredient in Radicava and Radicava ORS—could cause a type of allergic reaction that can be life-threatening.”
Radicava can be expensive. It is typically covered under Medicare Part B. Coverage through private insurance varies.
The Radicava website addresses many common questions. Ask your neurologist, ALS clinic team, and local ALS organization for their thoughts on whether it could help you.
Since Radicava’s release, there have been no other clinical trials. Some studies and reviews have highlighted its benefits, though others have questioned its effectiveness. Benefits may be more likely if you begin early in your disease progression.
Radicava was administered through intravenous infusions (IVs) until the oral formulation, Radicava ORS, was approved by the FDA in May 2022. The FDA writes: “Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral medication has the same dosing regimen as Radicava—an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.”
Regarding side effects, the FDA writes: “The most common side effects of Radicava are bruising (contusions), problems walking (gait disturbances), and headaches. Fatigue is also a possible side effect from Radicava ORS. Radicava and Radicava ORS can have serious side effects associated with allergic reactions including hives, rash, and shortness of breath. For patients with sulfite sensitivity, sodium bisulfite—an ingredient in Radicava and Radicava ORS—could cause a type of allergic reaction that can be life-threatening.”
Radicava can be expensive. It is typically covered under Medicare Part B. Coverage through private insurance varies.
The Radicava website addresses many common questions. Ask your neurologist, ALS clinic team, and local ALS organization for their thoughts on whether it could help you.
Nuedexta®
For ALS patients who experience pseudobulbar affect (PBA), which is characterized by sudden and unpredictable episodes of laughing or crying, Nuedexta is an FDA-approved oral medication that can help regulate emotional control.
Patients take two capsules per day and side effects are rare. A secondary benefit is that Nuedexta may improve speech and swallowing for some patients whose bulbar muscles have been affected. |
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Other treatments for ALS
Prescription drugs are not the only way people living with ALS can address symptoms, have a better quality of life, and potentially live longer.
- Studies have shown that attending an ALS clinic regularly can help extend your life by one year or more, in addition to improving your quality of life.
- Respiratory equipment, such as a bilevel machine, may also help you live longer. When breathing becomes more difficult, some people choose to extend their lives by getting a tracheotomy and going on full-time mechanical ventilation, though this requires 24/7 care.
- Getting a feeding tube can help you maintain your weight, have more energy, and get adequate nutrition and hydration.
- Some people living with ALS choose to explore non-pharmaceutical treatments such as supplements. Some alternative treatments have received positive clinical trial results.
Learn More
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