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Phase 3 Findings on Neffy for Pediatric Patients with Severe Allergies: A Conversation with Motohiro Ebisawa, MD, PhD


Dr Ebisawa details the findings he recently presented at the 2024 AAAAI annual meeting, including adverse events and next steps for the study.

In a recent interview with Patient Care Online, Motohiro Ebisawa, MD, PhD, discussed findings from a new phase 3 study on the use of the intranasal epinephrine treatment “neffy” among pediatric patients with severe allergies that he recently presented at the American Academy of Allergy, Asthma & Immunology 2024 annual meeting. Dr Ebisawa is the director of the Clinical Research Center for Allergy and Rheumatology at the Sagamihara National Hospital in Japan and has served as president of the World Allergy Organization.

The full interview follows here.

The following transcript has been edited lightly for style and flow.

Patient Care Online: To start, would you provide an overview of the clinical trial, you presented findings from at AAAAI 2024?

Dr Ebisawa: We performed the clinical trial using intranasal epinephrine, so called "neffy", for patients who reacted to causative food allergens during their oral food challenge test, which was performed last summer. We recruited about 80 patients with informed consent to get on the trial. Among them, 15 patients showed respiratory and gastrointestinal (GI) symptoms as the initial symptom, so that included those 15 patients for our study, and we excluded the patients showing just skin symptoms that could be recognized as mild symptoms. Neffy intranasal epinephrine, like intramuscular epinephrine, worked very well against those relatively severe allergic reactions (ie, anaphylaxis).

Patient Care: What were the main findings from the study?

Dr Ebisawa: Intranasal epinephrine was a unique approach to treat severe allergic reaction (ie, anaphylaxis) and people hesitate to use intramuscular due to the existence of the needle, so the product is very acceptable by the patient and guardians. We recruited children and also adolescents patients who have food allergy, relatively severe food allergies, in our study. The intranasal epinephrine was absorbed through the membrane existence of some kind, which enhances the penetration of the drug to our body. Neffy suppressed those respiratory and GI symptoms immediately after the treatment. Those were the main findings.

Patient Care: How do the results with the epinephrine nasal spray compare with what would be seen with epinephrine delivered by injection?

Dr Ebisawa: I did feel that the effect by intranasal epinephrine was almost identical to that of intramuscular epinephrine.

Patient Care: Can you discuss the adverse events exhibited by 7 participants?

Dr Ebisawa: We observed relatively minor adverse events. We observed irritation on the nasal membrane, probably due to the stimulation by epinephrine drug itself.

Patient Care: What, if any, are the next steps for this study?

Dr Ebisawa: Since our authority PMDA, equivalent to the FDA in the United States, had asked to perform this study in order to prove that intranasal epinephrine is really effective for human beings and the company performed a PKPD study against healthy branches, both in United States and in Japan. However, our authorities were not satisfied with those data so they requested that trial. And fortunately, in a hospital, we routinely perform oral food challenges, especially during the summer time. Patients experiencing severe food allergy performed the oral food challenge so that we could make it. It was a very difficult study, however, as a next step, we plan to submit the document to get the approval of the drug for the PMDA. I hope that we have a good result and a good discussion with them.

Patient Care: Thank you for taking the time out of your busy schedule to meet with me. Is there anything that I left out that you want to address?

Dr Ebisawa: Yes. Intranasal epinephrine was very acceptable by the patient and also guardians. Not only the 15 patients, but also the other 80 subjects on this trial gave us informed consent. And so that not like the intramuscular adrenaline patient and guardians, and possibly teachers and also nursery school staff usually hesitate to use intramuscular adrenaline in the case of anaphylaxis. However, if neffy is approved in Europe, United States, and Japan, that is going to be a life changing drug. That was the impression of this drug by myself and also our staff and patients and guardians.

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