Sodium phenylbutyrate and taurursodiol

(Relyvrio®)

Relyvrio®

Drug updated on 11/5/2024

Dosage Formsuspension (oral; sodium phenylbutyrate 3 g, taurursodiol 1 g)
Drug ClassUnknown
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.

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Summary
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  • This summary is based on the review of two randomized controlled trial(s). [1-2]
  • Functional Decline (ALSFRS-R Score): Sodium phenylbutyrate-taurursodiol (PB-TURSO) slowed the decline in the ALS Functional Rating Scale-Revised (ALSFRS-R) score over 24 weeks compared to placebo, with a mean rate of change of -1.24 points per month for the active drug versus -1.66 points per month for placebo. The difference was 0.42 points per month (95% Confidence Interval (CI), 0.03 to 0.81; P = 0.03).
  • Survival: Median overall survival was 25.0 months for participants randomized to PB-TURSO, compared to 18.5 months for placebo, reflecting a 6.5-month longer survival for the PB-TURSO group (hazard ratio, 0.56; 95% CI, 0.34-0.92; P = 0.023).
  • Secondary Outcomes: There were no significant differences between PB-TURSO and placebo in secondary outcomes, including isometric muscle strength, plasma phosphorylated neurofilament levels, slow vital capacity, and time to death or hospitalization.
  • Adverse Events: Adverse events associated with PB-TURSO were predominantly gastrointestinal in nature.
  • There is no information on significant safety concerns or adverse effects in specific population types or subgroups in the reviewed documents.
  • There is no population types or subgroups information available in the reviewed documents.

Product Monograph / Prescribing Information

Document TitleYearSource
Relyvrio (sodium phenylbutyrate and taurursodiol) Prescribing Information.2022Amylyx Pharmaceuticals, Inc., Cambridge, MA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Long-term survival of participants in the CENTAUR trial of sodium phenylbutyrate-taurursodiol in amyotrophic lateral sclerosis
135Subjects
F: 31%
M: 69%
2021Muscle & Nerve
Trial of Sodium Phenylbutyrate-Taurursodiol for Amyotrophic Lateral Sclerosis
135Subjects
F: 31%
M: 69%
2020The New England Journal of Medicine

Sex Distribution:

F:31%
M:69%
135Subjects

Year:

2020

Source:The New England Journal of Medicine