Neffy + Adrenaline for Allergy

Recruiting at 1 trial location

Overseen By Osnat Ehrman, MSc.

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: ARS Pharmaceuticals, Inc.

Disqualifiers: Significant medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate intervention during allergic reactions

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of two treatments, Neffy and IM Adrenaline, for individuals experiencing allergic reactions. It focuses on situations requiring an epinephrine shot after an allergy test or treatment. Participants must be at least 4 years old and have allergies that might require this treatment. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, allowing participants to contribute to understanding its benefits for more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for these treatments?

Previous studies tested neffy, a nasal spray for allergic reactions, on 175 adults with allergies but not severe reactions like anaphylaxis. The results showed that neffy is generally safe and offers a needle-free option for treating severe allergies.

Research has shown that intramuscular (IM) adrenaline is safe when used correctly. It is commonly used for severe allergic reactions, with the typical dose varying by age but considered safe for most people.

Both treatments are well-tolerated and effectively manage severe allergies. However, like any medicine, they can have side effects. Always consult a healthcare provider before considering participation in a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Neffy and IM adrenaline for allergy treatment because they offer unique advantages over traditional options like injectable epinephrine auto-injectors. Neffy is a nasal spray, providing a needle-free and user-friendly administration method, which could be particularly beneficial for those who are needle-averse or need a quick and easy option. This innovative delivery method makes it stand out by potentially increasing patient compliance and speed of action during allergic emergencies.

What evidence suggests that this trial's treatments could be effective for allergic reactions?

Research has shown that Neffy, a nasal spray for delivering epinephrine, effectively treated allergy symptoms in almost 90% of patients during food tests and allergy treatments. This success rate mirrors that of traditional adrenaline shots. Studies indicate that Neffy can quickly reduce allergy symptoms within 10 minutes of use. In this trial, some participants will receive Neffy, while others will receive adrenaline shots administered into the muscle, a well-known treatment for severe allergic reactions. Although one dose of adrenaline often helps, additional doses might be necessary to fully relieve symptoms. Both treatments have successfully managed allergic reactions. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals aged 4 and older, weighing at least 15 kg, who are undergoing oral food challenges or allergen immunotherapy. Participants must be able to consent (or have a legal representative consent) and require epinephrine treatment for an allergic reaction as determined by the study's investigator.

Inclusion Criteria

Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself

Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin

I am 4 years old or older and scheduled for an allergy test.

Exclusion Criteria

I have a health condition that makes it unsafe for me to receive epinephrine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Neffy or IM Adrenalin during allergic reactions after an oral food challenge or allergen immunotherapy

Immediate intervention during allergic reactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adrenaline
• Neffy

Trial Overview The study compares the safety of two treatments for severe allergies: Neffy and intramuscular Adrenalin. It focuses on patients experiencing allergic reactions after specific allergy tests that may need emergency intervention with epinephrine.

How Is the Trial Designed?

Group I: Neffy Active Control 1 Intervention

Group II: IM adrenaline Active Control 1 Intervention

Who Is Running the Clinical Trial?

ARS Pharmaceuticals, Inc.

Lead Sponsor

Trials

4

Recruited

660+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8139870/

Evidence update for the treatment of anaphylaxis - PMC ... IM adrenaline, but 98% will respond to 1 or 2 further doses. While effective for respiratory symptoms, a single dose of IM adrenaline has a limited effect ...

2. annallergy.org annallergy.org/article/S1081-1206(23)00404-0/fulltext

Innovations in the treatment of anaphylaxis: A review ... Data from these studies indicate promising pharmacokinetic results comparable to those of the standard of outpatient emergency care (0.3-mg EAI) ...

3. medscape.com medscape.com/viewarticle/higher-epinephrine-dose-tied-better-anaphylaxis-outcomes-2025a1000suh

Higher Epinephrine Dose Tied to Better Anaphylaxis ... An initial 0.3-mg intramuscular dose is less likely to resolve symptoms than a 0.5-mg dose.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39383344/

Adrenaline Auto-Injectors for Preventing Fatal Anaphylaxis We find that data support the effectiveness of intravenous adrenaline infusions for reversing physiological features of anaphylaxis.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825003757

Benefits of Epinephrine for Anaphylaxis Outweigh Potential ... Risk Factors for AEs With Epinephrine​​ Another study found that cardiac complications with IM epinephrine occurred at 3% (1 of 31) of older ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12328063/

Optimizing Adrenaline Administration in Anaphylaxis: Clinical ... Adrenaline is considered as a safe medication for the treatment of anaphylaxis when administered as per the recommended dose and route [34, 35].

7. mayoclinic.org mayoclinic.org/drugs-supplements/epinephrine-injection-route/description/drg-20072429

Epinephrine (injection route) - Side effects & dosage Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or ...

8. annallergy.org annallergy.org/article/S1081-1206(23)01304-2/fulltext

Anaphylaxis: A 2023 practice parameter update Intramuscular epinephrine is a safe medicine with negligible toxicity at doses recommended for anaphylaxis treatment (0.01 mg/kg of a 1:1000 ...

9. jacionline.org jacionline.org/article/S0091-6749(23)01059-X/fulltext

Pharmacokinetics/pharmacodynamics of epinephrine after ... Although epinephrine auto-injectors (EAIs) are safe and effective for the treatment of anaphylaxis, they are frequently considered inconvenient ...