It is interesting to read aboutanother respiratory nasal spray in the US which has avoided FDA drug approval by utilising non-drug lists that I think are not available with Australia TGA because everything with any therapeutic or prophylactic claims needs to be registered in the Australian Register of Therapeutic Goods ARTG before it can be sold in Australia.
The other "nasal cleanser" is Profi and has online sales also. Following website link to the SCIENCE https://www.profispray.com/pages/our-science takes you to https://www.biorxiv.org/content/10.1101/2023.10.02.560602v1.full.pdf.
This gives an explanation of how "PCANS were meticulously designed as a "drug-free" formulation, incorporating biopolymers, surfactants, and alcohols that are listed in the inactive ingredient database (IID) or generally recognized as safe107 (GRAS) list of the Food and Drug Administration (FDA), and are present as excipients in commercially available108 nasal/topical formulations".So by producing a "non-drug" nasal spray they can use these GRAS and IID lists of generically safe chemicals in small quantities. It goes on to say the PCANS non-drug ingredients include: gellan & pectin solutions were mixed with benzalkonium chloride (BKC), carboxymethylcellulose (CMC), hydroxypropyl methylcellulose (HPMC), carrageenan, xanthan gum, and Carbopol.There is also some reference to gums that are most suitable for spraying and in-vivo animal testing (mouse). Much of the "science" refers to benzalkonium chloride (BKC) which has some clear warnings of dangers in a Google Search.
It is also noted that the Profi website includes on line sales direct to Australia.
So this is presumably a United States competitor for Nasodine and is developed and promoted by a number Harvard academics (see the science paper). The avoidance of FDA drug approval does offer advantages which seems not to be available in Australia. Maybe manufacture plant for Nasodine in the US in the future will assist marketing. With an enormous US market conquered by a backdoor, it might stop the influence of Big Pharma on our TGA board and finally allow good antiviral nasal sprays like Nasodine and Viraleze in Australia.
All is not well with availability of SARS-CoV-2 treatments in Australia. We need to continue to be aware that Pfizer Paxlovid and Merck Lagevrio are STILL 2 years on from January 2022 when Head of TGA exempted himself from normal poison standard approvals process. Only Provisional Authorisations was given by TGA and they appear to have avoided the Marketing Approval requirement of presenting further research/studies to TGA to continue that authorisation or move to full Authorisation. Pfizer in June 2022 admitted in a discontinued study that only 51% efficacy (not statistically significant) was achieved when over 2000 vaccinated participants commenced a placebo based study and there are NO peer reviewed papers as proof of efficacy in normal populations and as for Lagevrio it was found to damage RNA in papers around August 2023 after EU EMA ceased recommending and in November WHO and FDA stopped recommending use in the community. We need to seriously ask why Australia's national stockpile still includes these very expensive and proven ineffective drugs whilst simple nasal sprays with good results have had to jump through whoops and wait far too long in such a cynical response of a national government to the Pandemic which is clearly not over.
I firmly believe a Royal Commission is needed to investigate what happened or maybe a referral to NACC if anyone can fund it.
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It is interesting to read aboutanother respiratory nasal spray...
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