Sodium phenylbutyrate/ursodoxicoltaurine

Sodium phenylbutyrate/ursodoxicoltaurine
Combination of
Sodium phenylbutyratePan-histone deacetylase inhibitor
Ursodoxicoltaurinebile acid
Clinical data
Trade namesAlbrioza, Relyvrio
Other namesAMX0035
AHFS/Drugs.comMultum Consumer Information
MedlinePlusa623014
License data
Routes of
administration		By mouth
ATC code
  • None
Legal status
Legal status
Identifiers
KEGG

Sodium phenylbutyrate/ursodoxicoltaurine, also known as sodium phenylbutyrate/taurursodiol and sold under the brand names Albrioza and Relyvrio, is a fixed-dose combination medication used for the treatment of amyotrophic lateral sclerosis (ALS).[2][4][6] It contains sodium phenylbutyrate and ursodoxicoltaurine (taurursodiol).[2]

The most common adverse reactions experienced with sodium phenylbutyrate/ursodoxicoltaurine include diarrhea, abdominal pain, nausea and upper respiratory tract infection.[7]

Sodium phenylbutyrate/ursodoxicoltaurine acts by blocking apoptotic pathways in the mitochondria and in the endoplasmic reticulum.[6] Sodium phenylbutyrate is a chemical chaperone that helps proteins maintain their normal conformation, preventing aggregation that may lead to cell death.[6] Ursodoxicoltaurine improves mitochondrial energy production.[6]

The combination was approved for medical use in Canada as Albrioza, in June 2022,[1][2][8] and in the United States, as Relyvrio, in September 2022.[5][9][7] The European Union's drug regulators refused to approve it, citing concerns about effectiveness.[10] In April 2024, the manufacturer announced that it is withdrawing the medication from the US and Canadian markets, due to it failing a key phase III clinical trial. [11]

  1. ^ a b "Qualifying notice for Albrioza". Health Canada. 13 June 2022. Archived from the original on 14 June 2022. Retrieved 13 June 2022.
  2. ^ a b c d "Albrioza monograph" (PDF). 1 June 2022. Archived (PDF) from the original on 14 June 2022. Retrieved 14 June 2022.
  3. ^ "Summary Basis of Decision (SBD) for Albrioza". Health Canada. 23 October 2014. Archived from the original on 24 January 2023. Retrieved 24 January 2023.
  4. ^ a b "Relyvrio- sodium phenylbutyrate/taurursodiol powder, for suspension". DailyMed. 30 September 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022.
  5. ^ a b "Drug Approval Package: Relyvrio". U.S. Food and Drug Administration (FDA). 27 October 2022. Archived from the original on 18 November 2022. Retrieved 18 November 2022.
  6. ^ a b c d "AMX0035". alsnewstoday. Archived from the original on 28 May 2021. Retrieved 15 June 2021.
  7. ^ a b "FDA Approves New Treatment Option for Patients with ALS". U.S. Food and Drug Administration (FDA) (Press release). 29 September 2022. Archived from the original on 29 September 2022. Retrieved 29 September 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ "Amylyx Pharmaceuticals Announces Health Canada Approval of Albrioza for the Treatment of ALS" (Press release). Amylyx. 13 June 2022. Archived from the original on 14 June 2022. Retrieved 13 June 2022.
  9. ^ "Amylyx Pharmaceuticals Announces FDA Approval of Relyvrio for the Treatment of ALS". Amylyx (Press release). 29 September 2022. Archived from the original on 29 September 2022. Retrieved 29 September 2022.
  10. ^ "Amylyx's ALS drug knocked back again in Europe". BioPharma Dive. Archived from the original on 19 January 2024. Retrieved 12 February 2024.
  11. ^ "Amylyx Pharmaceuticals Announces Formal Intention to Remove Relyvrio/Albrioza from the Market; Provides Updates on Access to Therapy, Pipeline, Corporate Restructuring, and Strategy". Amylyx Pharmaceuticals. 4 April 2024. Archived from the original on 4 April 2024. Retrieved 5 April 2024 – via Business Wire.