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New FDA-Approved Treatment Option for ALS

New FDA-Approved Treatment Option for ALS

In September 2022, the U.S. Food and Drug Administration (FDA) authorized the use of Relyvrio, which combines sodium phenylbutyrate and taurursodiol, as a new treatment option for amyotrophic lateral sclerosis (ALS). The launch is expected to happen in late October to early November 2022.

Based on current research, Relyvrio may slow down the progression of the disease and in turn, extend the lifespan of those who have ALS. Although larger-scale studies are necessary, the medication is promising enough that Amylyx Pharmaceuticals Inc. received the approval of the FDA.

What Is Amyotrophic Lateral Sclerosis or ALS?

Also known as Lou Gehrig’s disease, ALS is a degenerative medical condition that affects the neurons in charge of voluntary movements. This leads to the gradual loss of physical functions like movement, speech, and breathing in the final stages.

ALS symptoms can include:

  • Clumsiness in the hands
  • Cognitive and behavioral changes
  • Difficulties swallowing
  • Difficulty walking or performing daily activities
  • Frequent falls
  • Muscle cramps
  • Slurred speech
  • Weakness in the lower limbs

This condition typically appears first in the limbs before spreading to the rest of the body. Pain rarely occurs in the early stages but is common in the later ones as more neurons get destroyed.

How Do You Take Relyvrio?

Relyvrio is a powder medication that needs to be mixed with room-temperature water. You can then take it by mouth before a meal or a snack. It may also be delivered via a feeding tube. The recommended dosage is currently one packet daily for three weeks before increasing to one packet twice a day.

Possible Side Effects of Relyvrio

Common side effects of Relyvrio include:

  • Abdominal pain
  • Diarrhea
  • Nausea
  • Upper respiratory tract infection

Consulting your doctor to ensure that you are an appropriate candidate for Relyvrio helps ensure your safety and the effectiveness of this new treatment. Your physician can also educate you more precisely on possible adverse reactions based on your health.

How Clinical Trials Established Relyvrio ‘s Efficiency

Although current studies are unclear on how exactly Relyvrio slows down the progression of ALS, clinical assessments and the long-term study demonstrated that participants who had received Relyvrio experienced a longer survival than the control group who had received a placebo during a 24-week multi-center, randomized, and double-blind trial.

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