News
Published paper: Nasodine is an effective treatment for the common cold
Today, we announced that the results of the the first Phase 3 clinical trial of Nasodine Nasal Spray (Nasodine) as a treatment for the common cold (conducted in 2019) have been published in Frontiers in Medicine, a prestigious, high-impact journal.
The paper is titled: “Povidone-iodine nasal spray (Nasodine®) for the common cold: a randomised, controlled, double-blind, Phase III clinical trial”.
This is the first published study that supports the efficacy of Nasodine as a treatment for the common cold. The conclusion of the paper states:
“In the current study, Nasodine 0.5% PVP-I nasal spray demonstrated a consistently positive benefit in reducing overall cold severity outcomes compared with saline nasal spray. The benefit of Nasodine was most evident in its impact on functional impairment (quality of life) scores, where the results were statistically significant and clinical meaningful. In subjects who started treatment within the first 24h after symptom onset, the benefit of Nasodine over saline nasal spray was approximately 40%. It was safe and well tolerated. Nasodine is an effective and clinically meaningful treatment for the common cold.”
Until now, the results of that Phase 3 trial were unpublished, because of the long discussions with the TGA about approval of Nasodine in Australia between 2020 and 2023. The results of the 2019 study were at the centre of TGA’s review, so it could not be published until after the review and our subsequent appeals were completed.
The good news is that the TGA interactions and appeals, led to a detailed review and re-analysis of the trial data by clinical and statistical experts. These analyses and expert views have been incorporated into the published paper, leading to a much richer and more accurate understanding of the trial results.
The bottom line is that the authors concluded that “Nasodine is an effective and clinically meaningful treatment for the common cold.”
This paper will now be an important part of our marketing of Nasodine in those countries where the product can be legally sold – Singapore, Fiji and (soon) the Philippines.
It will also form a part of any future regulatory applications that may be needed for other countries.