Approved: New Formulation for ALS Rx

FDA approves oral formulation of edaravone for ALS

(RxWiki News) The US Food and Drug Administration (FDA) has approved an oral formulation for an amyotrophic lateral sclerosis (ALS) treatment.

This new approval is found under the name Radicava ORS (edaravone). It is available as a suspension that is taken by mouth in the morning.

This new approval is the oral version of Radicava (edaravone), which the FDA originally approved in 2017 to treat ALS. This medication was only available as an infusion to be administered into the vein — until now.

ALS, otherwise known as Lou Gehrig’s disease, is a rare disease that attacks and kills the nerve cells that control your voluntary muscles. Voluntary muscles are the ones responsible for talking, chewing, walking and even breathing.

ALS is a progressive disease, meaning it gets worse over time. According to the the Centers for Disease Control and Prevention, at least 16,000 Americans have ALS.

This approval offers a potentially exciting treatment option because it can be self-administered at home.

This medication requires you to be fasting. After fasting overnight, the patient takes it in the morning.

The most common side effects of this medication included bruising, problems walking and headaches. Another possible side effect was fatigue.

Allergic reactions (hives, rash and shortness of breath) were listed as a possible serious side effect tied to this medication.

Edaravone contains sodium bisulfite, which could lead to a life-threatening allergic reaction for those with a sulfite sensitivity.

This medication is manufactured by Mitsubishi Tanabe Pharma America, Inc.