EFA responded to the European Medicines Agency's (EMA) consultation on a concept note to develop new guidelines aimed at ensuring therapeutic equivalence between nasal medicinal products. These guidelines have the potential to make a significant impact on the accessibility and safety of treatments administered through the nose, as nasal sprays are becoming clear options to facilitate medicine intake more easy and faster.
Why are the guidelines important?
Nasal sprays medicines are fundamental treatments for patients living with conditions like allergic rhinitis. Now, there are also innovative nasal products enlarging patient choices, for example in emergency treatments and vaccines. Only in 2024, the EMA approved epinephrine nasal sprays for anaphylaxis (Eurneffy) and influenza vaccine nasal sprays (Fluenz). However, as nasal products differ a lot from other type of products, particularly orally inhaled products (OIPs), EMA has taken the step to develop a guideline specific to the risk-benefits of nasal treatments.
By establishing clear parameters for therapeutic equivalence, these guidelines could pave the way for a wider range of nasal medicines, giving patients more treatment options that are just as effective as existing products.
A path to easier and safer treatments
Nasal sprays clearly offer a less invasive treatment option compared to other methods. Patient groups like children and the elderly often struggle with devices that require a technique (inhalers) or are intrusive (injections), so the availability of treatment options as nasal sprays can make a big difference in their treatment experience. Additionally, nasal sprays could improve patient adherence to therapy, as they generally carry fewer risks and are easier to use.
EFA's call to action
In our response to the consultation, EFA emphasised the critical need to keep patients at the center of the process as more nasal sprays enter the market. We stressed that the EMA must ensure patients are well-informed, enabling them to make the best decisions for their health together with healthcare professionals. Patient education and clear communication are essential to helping individuals transition between treatments without disruption to their care.