Interim Decision Astodrimer sodium Poison Standard March 2025

https://www.tga.gov.au/sites/default/files/2025-03/public-notice-of-interim-decisions-acms46_accs40joint-acms-accs38-november-2024.pdf


Interim decision in relation to Astodrimer sodium

Proposal

The proposal is to classify astodrimer sodium vaginal gels for the treatment, relief and prevention of bacterial vaginosis (BV) as Pharmacy medicines (Schedule 2). These preparations are currently a Pharmacist Only medicine (Schedule 3). The application also proposed an amendment to the Appendix H entry that would permit advertising of all Schedule 3 preparations of astodrimer sodium. The current Appendix H entry only allows advertising of preparations for the treatment and relief of bacterial vaginosis and prevention of recurrent bacterial vaginosis (RBV).

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, the Delegate has, regarding the proposed amendments, made an interim decision to not amend the current Poisons Standard in relation to astodrimer sodium.

Reasons for the interim decision (including findings on material questions of fact)
I agree with the Committee's findings on the relevant provisions of section 52E of the Act.

I have made an interim decision to not amend the Poisons Standard with regards to astodrimer sodium.

I have considered the 12 public submissions received during the pre-meeting consultation period. Interested parties were given the choice to indicate their support or opposition to the proposed amendments with or without providing a written component. Seven of the supportive submissions provided written responses highlighting astodrimer sodium as a safe and effective non-antibiotic treatment option for BV and prevention of RBV. Increasing access to an efficacious product for the treatment of a common condition as BV is in the interest of public health. It also poses no risk of contributing to antibiotic resistance.

The partially supportive submission proposed that astodrimer sodium be included in both Schedule 2 and Schedule 4 of the Poisons Standard and urged consideration of astodrimer sodium to be a prescription medicine for BV treatment. Inclusion in Schedule 2 will allow better access for effective medication against BV while inclusion in Schedule 4 will facilitate products to be listed in Pharmaceutical Benefits Scheme where reasonably priced medically supervised treatment is needed and appropriate, for example for treatment of COVID-19 in generally healthy people under 70 years of age.

The 3 opposing submissions acknowledged the safety profile of astodrimer sodium being commensurate with Schedule 2 but raised concerns regarding the risk of misdiagnosis of BV by the patient. Consultation with a pharmacist is likely to provide appropriate guidance and timely referral to a doctor. Additionally, the required advisory statements for labelling for astodrimer sodium vaginal gel products are based on the Schedule 3 supply restrictions in Australia.

BV is an imbalance in the normal vaginal flora and not an infection caused by a specific pathogen. It is a very common condition in women, with an estimated global prevalence of 23-29% among women of reproductive age.13

Astodrimer sodium is a highly branched molecule that has a polyanionic surface which binds to virus outer coat proteins and blocks virus attachment and/or adsorption to cells to prevent infection. It is an option for the treatment of BV, common sexually transmitted infections (STIs) including HIV, HSV and HPV, and cold and respiratory viruses. With reference to s 52E(1)(b) and (d) of the Act, I note that astodrimer sodium is available for the treatment of BV as a vaginal gel containing 1% w/w astodrimer sodium.

With regards to s 52E(1)(a) and (e) of the Act, while astodrimer sodium poses a low risk of toxicity and is not systemically absorbed, I agree with the concerns expressed by the Committee around the risks of misdiagnosis and inappropriate use of the substance for BV. The clinical presentation of BV often overlaps with other conditions, including vulvovaginal candidiasis (thrush), STIs and urinary tract infections (UTI). Self-testing devices do not eliminate the potential for misdiagnosis and consumers may misinterpret their symptoms and incorrectly self-diagnose conditions such as STIs or UTIs to be BV. Given the overlapping symptoms, and potential consequences of misdiagnosis, treatment of BV requires health professional intervolvement. Further, vaginal candidiasis has a similar disease risk profile to BV with less serious complications and all the currently marketed vaginal candidiasis treatments are at least Pharmacist only medicines (Schedule 3).

In considering s 52E(1)(f) of the Act, references to BV and RBV in advertising about therapeutic goods are considered as restricted representations. This is because BV and RBV are considered as serious forms of a disease, condition, or ailment that require diagnosis or treatment or supervision by a suitably qualified health practitioner.

In summary, diagnosis of BV is substantially safer with pharmacist oversight to mitigate the risk of consumer misdiagnosis and provision of appropriate advice for the prevention of BV. I agree with the advice of the Committee that the current scheduling of astodrimer sodium remains appropriate, and no changes should be made to its scheduling.