Tuesday, July 16, 2024

Nasal Spray Nears Approval in Europe as Alternative to Epinephrine Autoinjectors for Allergic Reactions

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Nasal spray as an alternative to epinephrine autoinjectors, is nearing approval in Europe after receiving a recommendation from the European Medicines Agency’s (EMA) human medicines committee. This new product, ARS Pharma’s Eurneffy, is set to become the first intranasal formulation of epinephrine available in the EU for the emergency treatment of life-threatening allergic reactions, such as anaphylaxis.

The Committee for Medicinal Products for Human Use (CHMP) of the EMA has given a positive verdict, marking a significant achievement for ARS Pharma. This recommendation follows a challenging period for the company, as its marketing application for the product under the brand name Neffy was rejected by the U.S. Food and Drug Administration (FDA) last year. The FDA requested an additional efficacy study to assess the drug’s performance in repeat doses, a decision that contradicted the advice of its expert advisors.

The FDA’s specific request was for a study involving two doses of epinephrine administered via nasal spray in individuals with nasal congestion due to allergic rhinitis. This study was to compare these results with those of similar patients receiving two doses of epinephrine via syringe, ensuring that the properties of neffy were comparable. ARS Pharma was surprised by this decision, especially since they had reached an agreement with the FDA on physician labeling and post-market requirements, including a repeat-dose study. Consequently, ARS Pharma has refiled neffy with the FDA, and a decision is anticipated by October 2nd.

Nasal Spray for Allergic Reactions Shows Comparable Efficacy to Injectable Epinephrine

Conducting a direct comparison between EURneffy and injectable epinephrine in a randomized controlled trial would not be feasible or ethical. Instead, ARS Pharma focused its comparison on pharmacodynamic measures, such as blood pressure and heart rate, and pharmacokinetics, including how the medicine is absorbed, modified, and eliminated from the body. The CHMP has been convinced by ARS Pharma’s data, acknowledging that the effects of nasally administered adrenaline are comparable to those of intramuscular injections.

Epinephrine autoinjectors like Viatris’ Epipen and its generics have proven to be highly effective when used correctly. However, some patients and caregivers delay or avoid administering the treatment in emergencies due to needle phobia, lack of portability, or the fear of administering an injection without medical training. The introduction of a nasal spray alternative could address these concerns, potentially leading to quicker and more widespread usage in emergencies.

Nasal Spray

ARS Pharma’s Nasal Spray Set to Revolutionize Allergy Treatment

Analysts at William Blair have previously estimated that the intranasal product could generate peak sales of around $750 million in the U.S. alone. This projection was made before the FDA rejection, but there is still optimism for the product’s market potential. If Neffy is approved for additional indications, ARS Pharma could see even higher sales figures. The company plans to conduct an outpatient study of the drug in individuals with hives (urticaria) later this year, which could expand its market reach.

According to the European Academy of Allergy and Clinical Immunology (EAACI), allergy is the most widespread chronic disorder in Europe, affecting 150 million Europeans in 2015. The EMA reports that around one in five people living with severe allergic conditions live in constant fear of anaphylactic shock or death from an allergic reaction. This underscores the significant need for effective and user-friendly emergency treatments like EURneffy.

In summary, the recommendation by the CHMP for the approval of ARS Pharma’s EURneffy represents a crucial step towards providing a new, non-injectable option for emergency anaphylaxis treatment in Europe. This innovative nasal spray could revolutionize the way severe allergic reactions are managed, making life-saving treatment more accessible and less intimidating for patients and caregivers alike. The decision now awaits final approval, which could open the doors to significant advancements in allergy management and emergency response.

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Resource: Europen Medicines Agency, June 28, 2024

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