The US Food and Drug Administration (FDA) has approved an oral version of edaravone (Radicava ORS) for adults with amyotrophic lateral sclerosis (ALS).
Edaravone is a pyrazolone free radical scavenger that is thought to reduce the effects of oxidative stress, a potential factor in the onset and development of ALS.
As I mentioned Medscape Medical NewsThe drug was first approved in 2017 as an intravenous (IV) infusion to treat amyotrophic lateral sclerosis.
Radicava ORS is self-administered and can be taken at home. After an overnight fast, Radicava ORS should be taken in the morning orally or through a feeding tube.
The oral version contains the same dosing regimen as the original IV version, with an initial 14-day daily dosing treatment cycle, followed by a 14-day drug-free period and subsequent treatment cycles consisting of 10 daily doses of 14-day periods, followed by drug-free periods for 14 days.
The FDA said that compared to the IV formulation of Radicava, Radicava ORS has been shown to generate similar levels of the active drug in the bloodstream.
The U.S. Food and Drug Administration (FDA) determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals randomized to receive either the drug or placebo.
At 24 weeks, individuals receiving Radicava showed a lower clinical assessment of daily functioning compared to those receiving a placebo.
The most common side effects of Radicava are bruising, trouble walking, and headache.
Fatigue is also a possible side effect of Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rashes, and shortness of breath.
Complete prescribing information, including additional information on the risks associated with Radicava ORS, is available online.
Amyotrophic lateral sclerosis is a rare disease that affects about 16,000 people in the United States, according to the latest data from the Centers for Disease Control and Prevention.
The FDA granted Radicava ORS orphan drug status, priority review, and fast-track designations.
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