Drug updated on 4/18/2024
| Dosage Form | Suspension (oral; sodium phenylbutyrate/taurursodiol: 3g/1g) |
| Drug Class | Phenylacetate prodrugs and ambiphilic bile acids |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
Summary
- Sodium phenylbutyrate and taurursodiol (Relyvrio) is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults, with a phase II clinical trial showing slower disease progression and extended survival compared to placebo.
- The information was derived from one systematic review/meta-analysis study that provided comprehensive data on Relyvrio's safety and efficacy in treating ALS.
- Although no direct comparison between sodium phenylbutyrate/taurursodiol (Relyvrio) and other existing ALS treatments such as riluzole or edaravone was made, the study suggests potential benefits of this drug due to its observed effects on slowing disease progression.
- The US Food & Drug Administration has approved Relyvrio as an oral suspension for ALS, indicating its potential utility; however, further data from phase III studies are needed to better understand its long-term safety profile.
- Given the high unmet need in ALS treatment, sodium phenylbutyrate/taurursodiol could represent a valuable addition to available therapies according to the reviewed study.
- While promising results have been shown by using sodium phenylbutyrate/taurursodiol (Relyvrio), additional studies are required for thorough comparisons with currently available treatments' effectiveness and safety profiles.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Relyvrio (sodium phenylbutyrate and taurursodiol) prescribing information. | 2022 | Amylyx Pharmaceuticals, Inc, Cambridge, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Sodium phenylbutyrate and taurursodiol: a new therapeutic option for the treatment of amyotrophic lateral sclerosis. | 2024 | Annals of Pharmacotherapy |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Iranian clinical practice guideline for amyotrophic lateral sclerosis. | 2023 | Frontiers in Neurology |