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Revised final decisions amending, or not amending, the current Poisons Standard to correct for minor administrative errors, September 2018

Scheduling medicines and poisons

28 September 2018

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4.1 Sodium oxybate

Part B: Amendments to the Poisons Standard not referred to an expert advisory committee

4. Delegate-only decisions on agricultural and veterinary chemicals

4.1 Sodium oxybate

Delegate's final decision

The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Poisons Standard by creating a new Appendix K entry for sodium oxybate as follows:

Appendix K - New Entry

SODIUM OXYBATE

Implementation date: 1 October 2018
Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered by the delegate for the decision include:

  1. the risks and benefits of the use of a substance:
    • A common side effect of sodium oxybate is somnolence.
Scheduling proposal and reasons for proposal

The delegate of the Secretary proposed to amend the Poisons Standard with respect to sodium oxybate. The proposed amendment was as follows:

Appendix K - New Entry

SODIUM OXYBATE

My reasons for the proposal were:

  • A common side effect of sodium oxybate in somnolence. However, it is not listed in Appendix K of the Poisons Standard.
Background information for sodium oxybate
Current scheduling status

Prior to this final decision sodium oxybate was listed in Schedule 8 and Appendix D of the Poisons Standard as follows:

Schedule 8

# SODIUM OXYBATE for human therapeutic use.

Appendix D, Item 1

SODIUM OXYBATE for human use.

Sodium oxybate is also a derivative of 4-hydroxybutanoic acid and its salts listed in Schedule 9 of the Poisons Standard as follows:

Schedule 9

4-HYDROXYBUTANOIC ACID and its salts except for sodium oxybate when in Schedule 8. *(GAMMA HYDROXYBUTYRATE (GHB)).

Index

GAMMA HYDROXYBUTYRATE
cross reference: 4-HYDROXYBUTANOIC ACID, GHB, SODIUM OXYBATE

Scheduling history

In November 1991, an applicant wrote to the Drugs and Poisons Scheduling Sub-Committee (DPSSC) requesting that consideration be given to the scheduling of sodium oxybate (gamma hydroxybutyrate) after reports from the United States of America (USA) indicated potential for misuse and serious side effects. The committee felt that more information was required and sought further information from the Drugs of Dependence (DOD) branch, the TGA and State/Territory DPSSC members.

At the May 1992 meeting, the committee noted that gamma-hydroxybutyrate (sodium oxybate) was being used in conjunction with illicit amphetamines and being used as a substitute for anabolic steroids by the fitness/bodybuilding industry. It was also reported that GHB was being sold as 'Fantasy' in night clubs at $80 for 5 grams. As the substance had no approved therapeutic use or safety assessment, the committee felt that scheduling was not appropriate and suggested the DOD branch make the substance a prohibited import.

In November 1994, GHB was on the agenda again and the committee recommended the matter be referred to the Ministerial Committee on Drug Strategy after it was noted that it was a substance of concern to the Australian Bureau of Criminal Intelligence due to substance related deaths in the USA.

In November 1996, the committee approved an out of session Schedule 9 proposal for sodium oxybate. The committee agreed to create a new Schedule 9 entry for 4-hydroxybutanoic acid. However, due to concerns that the entry may inadvertently capture derivatives that were not of concern, the committee agreed to amend the entry to read 4-hydroxybutanoic acid and its salts so that salts could be clearly captured by the entry. Sodium oxybate was also added to the index entry for 4-hydroxybutanoic acid as a cross reference.

In June 2002, the NDPSC considered gamma-butyrolactone (GBL) as a possible derivate of GHB and as a result, the 4-hydroxybutanoic acid entry was reviewed. The committee agreed that the current scheduling of 4-hydroxybutanoic acid is consistent with the committee's intent to exclude other derivatives of 4-hydroxybutanoic acid, except its salts, from the requirements of scheduling. This was due to them being appropriately controlled through other State and Territory mechanisms. Therefore, GBL remained unscheduled.

In March 2014, the Advisory Committee on Medicines Scheduling (ACMS) considered a proposal to create new entries for sodium oxybate in Schedule 8 and Appendix D, Item 1. The committee recommended that the new entries be created for sodium oxybate due to it being safe and efficacious at the therapeutic dose of 9 grams, the therapeutic need and the low potential for abuse. The committee also recommended that the Schedule 9 GHB entry be amended to exclude the Schedule 8 entry for sodium oxybate. The delegate agreed with the committee and the new entries were implemented 1 October 2014.

Australian regulations

The Australian Register of Therapeutic Goods (ARTG) has no products containing sodium oxybate.

Sodium oxybate does not appear in the current Therapeutic Goods (Permissible Ingredients) Determination No.5 of 2017 as it is a scheduled substance and is not eligible for use in ARTG listed medicines.

In the last 30 years there have been no reported cases of adverse events related to sodium oxybate in the Database of Adverse Events Notification (DAEN) - Medicines.

International regulations
  • USA: sodium oxybate is classified as a prescription medicine.
  • European Union (EU): The European Commission granted a marketing authorisation valid throughout the EU for Xyrem® on 13 October 2005.
  • Canada: Health Canada regulates sodium oxybate as a 'Narcotic (CDSA I)' medicine.
  • United Kingdom (UK): sodium oxybate is classified as a prescription medicine.
Substance summary

Sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB) and is a central nervous system depressant which is used to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy and modifies sleep architecture reducing fragmented night-time sleep. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The precise mechanism by which sodium oxybate produces an effect is unknown. However, sodium oxybate is thought to act by promoting slow (delta) wave sleep and consolidating night-time sleep.

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • Section 52E (1) of the Therapeutic Goods Act 1989 in particular: (a) the risks and benefits of the use of a substance.

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