Posted: 23 February 2023
Firebrick Pharma announced plans to develop Nasadine Nasal Spray for use in children as well as adults. The plans were outlined in a Paediatric Investigation Plan (PIP) that was filed with the European Medicines Agency (EMA).
The PIP is a prerequisite to filing the full application for marketing approval in Europe, called an MAA (Marketing Authorisation Application), which we hope to do later this year once we have the results of our current Phase 3 trial in adults.
However, the PIP also signals an important development for Nasodine, which is the planned expansion of Nasodine use from adults to adolescents 12-17 years old and then potentially to children 6-11 years old.
If this program is successful, it would represent a major expansion of the addressable market for Nasodine. It would also be a boon for parents everywhere. 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 huge benefit.
