Epinephrine nasal spray reversed allergic reactions minutes after administration, results significant for quest to win FDA approval
USA: A small observational study showed that administering one intranasal epinephrine dose immediately after observing a grade 2 allergic reaction led to skipping a second dose of epinephrine within 15 minutes in all 15 pediatric patients.
"Neffy appears to be an effective needle-free option for treating anaphylactic symptoms," the researchers wrote.
The intranasal epinephrine spray ARS-1 (also known as neffy), despite being eluded from FDA approval, continues to build its case with findings of resolved allergic symptoms in children and teenagers undergoing an oral food challenge, and a separate study showed that it maintained its potency under extreme temperatures.
It took a median of 16 minutes to fully resolve grade 2 reactions to grade 0. Following the intranasal administration, respiratory, gastrointestinal, skin and mucosal symptoms all began to decrease within the first 5 minutes, reaching full resolution in a median of 15, 15.5, and 35 minutes, respectively, Motohiro Ebisawa, MD, PhD, of the Clinical Research Center for Allergy and Rheumatology at NHO Sagamihara National Hospital in Kanagawa, Japan, said at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.
Gastrointestinal, respiratory, and skin and mucosal symptoms all began to decrease within the first 5 minutes following the intranasal administration, reaching full resolution in a median of 15, 15.5, and 35 minutes, respectively, reported Motohiro Ebisawa, MD, PhD, of the Clinical Research Center for Allergy and Rheumatology at NHO Sagamihara National Hospital in Kanagawa, Japan.
one patient did develop a biphasic allergic reaction about 2 hours and 45 minutes following administration -- they were subsequently treated with epinephrine, Ebisawa reported.
The study marks another step in the quest for epinephrine nasal spray to win FDA approval.
The study included 15 pediatric patients experiencing grade 2 or higher allergic symptoms induced by an oral food challenge, leading to 18 observed reactions. Patients' ages ranged from 6 to 17 years. Participants received a 2.0-mg dose of the intranasal product if they weighed below 30 kg (n=6), otherwise a 2.0-mg dose (n=9).
The one patient with grade 2 cardiovascular (CV) symptoms resolved to grade 0 at 32 minutes after intranasal administration (no grade 1 exists for these symptoms).
Regarding safety, ten patients had a treatment-emergent adverse event: six were deemed nasal spray-related, and four were judged to be a result of the oral food challenge and unrelated to treatment.
Developer ARS Pharmaceuticals tried last year to get FDA approval as the first non-injectable treatment for type 1 allergic reactions such as anaphylaxis but failed. Despite a favourable endorsement from the FDA's Pulmonary-Allergy Drugs Advisory Committee for use in adult and pediatric patients, the agency ultimately requested that an additional premarket study -- on repeat doses under allergen-induced allergic rhinitis conditions -- be performed before approval may be considered again.
ARS Pharmaceuticals stated that it would submit a request for a formal dispute resolution to appeal the agency's decision and resubmit the application to the agency likely in the first half of 2024.
If the intranasal product gets approval on the second try, it would be the first needle-free form of epinephrine.
While allergen avoidance is used for preventing type I allergic reactions, epinephrine remains the first-line emergency treatment in the event of a reaction. Barriers to use include, however, a fear of needles or issues surrounding correct administration that can delay or prevent crucial treatment.
ARS has investigated other factors that might deter patients from epinephrine use, and AAAAI presented other research demonstrating that its nasal spray maintains its potency following prolonged exposure to different temperatures.; 6 months at 40° C (104° F): -13.9%, -27.5%, and -17.2%, respectively, and 3 months at 50° C (122° F): -8.6%, -41.6%, and -56.6%.
Under room temperature conditions for six months, the intranasal product dropped in potency (7.7%), while the autoinjector's potency dropped by 4.9%, and the prefilled syringe formulation dropped by 10%, the study showed.
Current regulatory specifications for the shelf life of an epinephrine product allow for a 20% reduction in potency.
According to Richard Lowenthal, president and CEO of ARS Pharmaceuticals, while allowing the intranasal product to freeze isn't ideal, as it will not be available for immediate use, it can still be thawed for use later on.
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