Firebrick Pharma announced that it has filed a Pediatric Investigation Plan (PIP) with the EMA’s Pediatric committee for its Nasodine povidone-iodine nasal spray as the company plans to submit a marketing application for Nasodine by the end of 2023. In April 2022, Firebrick initiated a Phase 2 study of Nasodine for the treatment of COVID-19. A Phase 3 trial of Nasodine for the common cold was initiated the next month, and the company says that it expects to complete a second Phase 3 trial of Nasodine for the common cold this year.
According to Firebrick, the plan includes two pediatric trials, one in children aged 12-17 using the same dose as for adults and another trial in children aged 6-11 using a lower dose and a smaller delivery device. The pediatric trials would be initiated following approval of Nasodine for use in adults. Firebrick said that it is requesting to evaluate safety and compliance but not efficacy in the pediatric trials, arguing that “efficacy as a treatment for the common cold can be extrapolated from the results of the adult Phase 3 trials.”
Firebrick Executive Chairman Peter Molloy commented, “The PIP can often take up to nine months to be accepted by the PDCO, so filing it at this time was critical to achieving our planned filing of the Nasodine MAA later this year, after we have the results of our second pivotal common cold trial in adults. As every parent knows, children suffer a much higher frequency of colds than adults and often pass on the infection to other family members. Having Nasodine approved for use in children would be a boon for parents everywhere, and a significant expansion of the addressable market for Nasodine.”
Read the Firebrick Pharma press release.
