Firebrick Pharmaceuticals announced that it has withdrawn its appeal of a decision by the Therapeutic Goods Administration (TGA), which refused to approve the company’s Nasodine povidone-iodine nasal spray as a treatment for the common cold. Firebrick said that the withdrawal was due to “the significant distraction and legal costs associated with proceeding,” especially since the company had already decided to market the nasal spray in other countries as a nasal disinfectant.
In March 2023, Firebrick said that it was re-starting a Phase 3 trial of Nasodine in patients suffering from colds. The company announced a change in strategy in November 2023, saying that an investigation of the Phase 3 results found “inaccuracies in trial efficacy data” with “an incongruous convergence between the placebo and active” in the 2023 study.
In the November announcement, Firebrick Executive Chairman Peter Molloy said, “We firmly believe Nasodine works as a treatment for the common cold, if used at the first signs of a cold, but demonstrating that fact in a natural setting trial design is challenging.”
At that time, the company said that it would continue developing the nasal spray for the common cold but had said that “the Company now has regulatory advice that Nasodine can be legally marketed in several countries as a nasal antiseptic/disinfectant without further clinical studies. For commercial reasons, the Company cannot disclose which countries, but sales are expected to commence in 2024.”
Read the Firebrick Pharmaceuticals announcement on withdrawal of the appeal.
