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  1. Key Messages. Treatment with riluzole may provide clinical benefits for patients with amyotrophic lateral sclerosis, including longer survival time, reduced risk of disease progression, and minor reversible adverse events, compared to no treatment with riluzole or a placebo.

  2. Riluzole was approved by the US FDA in 1995 as the first drug to treat ALS. Although riluzole is generally safe and well tolerated in clinical practice, its efficacy in ALS is modest, prolonging tracheostomy-free survival by only 2-3 months.

    • Yuji Saitoh, Yuji Takahashi
    • 2020
    • Qalsody
    • Relyvrio
    • Radicava™
    • Rilutek
    • Tiglutik
    • Exservan™
    • NUEDEXTA®

    Qalsody, also known as tofersen or BIIB067, was developed to treat ALS associated with a mutation in the superoxide dismutase 1 (SOD1) gene. The FDA approved Qalsody for use to treat SOD1-ALS in 2023. Learn more.

    RELYVRIO is a combination of two drugs, sodium phenylbutyrate and taurursodiol, which act to prevent nerve cell death by blocking stress signals in cells. The FDA approved RELYVRIO for use to treat ALS in 2022. Learn more.

    The FDA approved Radicava™ in 2017, making it the first new treatment specifically for ALS in 22 years. An oral formulation was approved in 2022. Learn more.

    This was the first FDA-approved drug available to treat ALS — in 1995. It inhibits glutamate release and prolongs life approximately three months. Riluzole is the generic name of Rilutek.

    The first and only thickened liquid form of riluzole, Tiglutik was approved by the FDA in September 2018. This formulation contrasts with the oral pill form of riluzole that has been on the market for ALS for more than 20 years. It is designed to avoid potential problems of crushing tablets. Learn more.

    An oral film formulation of riluzole, Exservan was approved by the FDA in November 2019. This formulation contrasts with the oral pill form of riluzole that has been on the market for ALS for more than 20 years and developed for patients with severe swallowing difficulties. The oral film is placed on top of the patient’s tongue and dissolves bypass...

    Indicated for the treatment of pseudobulbar affect (PBA), which is characterized by frequent, involuntary, and often sudden episodes of crying and/or laughing that are exaggerated and/or don’t match how you feel. PBA occurs secondary to a variety of otherwise unrelated neurologic conditions. Nuedexta® (dextromethorphan HBr and quinidine sulfate) wa...

  3. Riluzole is the only drug to prolong survival for amyotrophic lateral sclerosis (ALS) and, at a dose of 100 mg, was associated with a 35% reduction in mortality in a clinical trial. A key question is whether the survival benefit occurs at an early stage of disease, late stage, or is spread throughout the course of the disease.

    • Ton Fang, Ahmad Al Khleifat, Jacques-Henri Meurgey, Ashley Jones, P Nigel Leigh, Gilbert Bensimon, A...
    • 10.1016/S1474-4422(18)30054-1
    • 2018
    • Lancet Neurol. 2018 May; 17(5): 416-422.
  4. 14 de mar. de 2012 · Types of participants: adults with a diagnosis of amyotrophic lateral sclerosis. Types of interventions: treatment with riluzole or placebo. Types of outcome measures: Primary: pooled hazard ratio of tracheostomy‐free survival over all time points with riluzole 100 mg.

    • Robert G Miller, J D Mitchell, Dan H Moore
    • 10.1002/14651858.CD001447.pub3
    • 2012
    • 2012/03
  5. PMID: 32573277. DOI: 10.1080/21678421.2020.1771734. Abstract. To compare the effect of riluzole on median survival in population studies of patients with amyotrophic lateral sclerosis (ALS) with that observed in clinical trials.

  6. 7 de mar. de 2018 · We showed that riluzole prolongs survival in the last clinical stage of ALS; this finding needs to be confirmed in a prospective study, and treatment effects at stage 1 still need to be analysed. The ALS stage at which benefit occurs is important for counselling of patients before starting treatment.