Message to the TGA

Dear TGA,

There has been an amount of critical press concerning TGA’s position in regard to an anti viral nasal spray named Viraleze, containing astodrimer sodium, a patented polymer developed by Starpharma Ltd. Application was made for the approval of this spray for the deactivation of a number of viruses including SARS-COV-2 in its various forms.

It seems that part of the problem for the TGA is that this active ingredient is already approved in a medical device for the treatment of bacterial vaginosis. In that earlier approval TGA took the step of including astodrimer sodium on the poisons standard, Schedule 3. The therapeutic action of astodrimer sodium is that it forms a antibacterial and antiviral barrier on mucous membranes. TGA has accepted that the absorption into the body is minimal, even negligible. There is ample scientific data on the mode of action which I need not repeat here.

I should point out that TGA is the ONLY regulatory body, globally, that I am aware of, that has regulated the sale of this topical treatment. Therein lies the problem!

There is ample evidence of the safety of the active ingredient and no regulatory body has suggested otherwise.

So the obvious and practical solution to this problem is to remove astodrimer sodium from Schedule 3 of the Poisons Standard. This would bring Australia into line with the UK, Europe and a number of other countries who have approved it. One might also observe that one mucous membrane in the body is much like another and approval for vaginal use but not nasal use is somewhat illogical.

TGA would be aware of other nasal sprays which have been approved as medical devices, including retail products like Vic First defence and others with a far less anti viral effectiveness.

In closing I would also observe that astodrimer sodium is approved by the TGA as a condom lubricant. As such the ingredient would, I suggest, find its way onto mucous membranes wherever they are.

I suggest the smart thing to do is to follow sister regulators and remove astodrimer sodium from the poisons register, allowing TGA to approve the nasal spray without further ado. Australia needs protection against these viruses, over and above that provided by vaccination.

Yours