FMXIN002 vs EpiPen for Allergy

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Nasus Pharma

Disqualifiers: Neurologic, Cardiovascular, Psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering epinephrine, the medicine used in EpiPens, through a nasal spray called FMXIN002. The goal is to compare how the body absorbs and responds to this method versus the traditional EpiPen injection. Participants will receive the nasal spray in either the same nostril or different nostrils to assess effects. The trial seeks healthy adults with a history of frequent seasonal allergies or hay fever. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative nasal spray.

Do I need to stop my current medications to join 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.

Is there any evidence suggesting that FMXIN002 is likely to be safe for humans?

Research has shown that FMXIN002, a nasal spray form of epinephrine, is generally safe and well-tolerated. In a study with 12 healthy adults who had seasonal allergies, participants received doses of FMXIN002. The results showed that it was absorbed quickly and effectively without major side effects. Another source highlights that FMXIN002 offers a needle-free and easy-to-use alternative to traditional epinephrine injectors, like the EpiPen. It can also be stored at room temperature, making it more convenient and safe. Overall, FMXIN002 appears to be a promising and safe option for those needing emergency allergy treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

FMXIN002 is unique because it delivers epinephrine as a nasal powder spray, offering a potentially quicker and easier way to treat allergic reactions compared to traditional EpiPens, which require injection. This treatment also explores the effectiveness of dosing in the same nostril versus alternating nostrils, potentially optimizing how the medication is absorbed. Researchers are excited about FMXIN002 because it could provide a needle-free option that is more convenient for patients, especially those who are needle-averse or need to administer the treatment quickly in an emergency.

What evidence suggests that FMXIN002 might be an effective treatment for allergic rhinitis?

Research has shown that FMXIN002, a nasal spray containing epinephrine powder, might be a promising treatment for allergies. Studies have found that FMXIN002 allows faster and better absorption of epinephrine, crucial for quickly treating allergic reactions. Specifically, previous patients demonstrated that FMXIN002 can work as well as, or even faster than, traditional epinephrine injections like the EpiPen. In this trial, participants will receive repeated doses of FMXIN002 either in the same nostril or in both nostrils. The nasal spray is easy to use because it doesn't involve needles and remains stable at room temperature, making it convenient for everyday use. These findings suggest that FMXIN002 could be an effective alternative for people with allergies. ^{1 2 3 6 7}

Who Is on the Research Team?

Mark L Freedman, MD, FRCPC

Principal Investigator

Pharma Medica Research, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults with allergic rhinitis who can safely receive epinephrine. It's not suitable for those with certain allergies, anaphylactic reactions, or conditions that could interfere with the study.

Inclusion Criteria

Willing and able to remain in the clinic for the entire duration of the confinement period

Be informed of the nature of the study and give written consent prior to any study procedure

Documented positive skin allergy test at screening

Exclusion Criteria

History of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results

Have clinically significant findings at screening

I have not changed or stopped using hormonal birth control recently, and I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and repeat doses of FMXIN002 and EpiPen under normal and nasal congestion conditions

1 day

Single visit for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FMXIN002

Trial Overview

The study compares FMXIN002, a new intranasal epinephrine powder, to the standard EpiPen autoinjector. Participants will receive single and double doses of each treatment to assess how their bodies absorb and respond to them.

How Is the Trial Designed?

Group I: FMXIN002 Repeated doses in the same nostril Experimental Treatment 6 Interventions

Repeated doses of epinephrine nasal powder spray, in the same nostril, 10 minutes apart.

Group II: FMXIN002 Repeated doses in the opposite nostril Experimental Treatment 6 Interventions

Repeated doses of epinephrine nasal powder spray, in both nostrils, 10 minutes apart.

Who Is Running the Clinical Trial?

Nasus Pharma

Lead Sponsor

Trials

4

Recruited

760+

Citations

1.

jacionline.org

jacionline.org/article/S0091-6749(24)01585-9/fulltext

Fast Acting, 5 years stable Intra-Nasal Powder-Spray ...

Study #1(NCT04696822): 12 healthy adults with seasonal allergic rhinitis received FMXIN002 1.6mg and 3.2mg +/- a nasal allergenic challenge. The results without ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07045701

NCT07045701 | FMXIN002 in Patients at Risk of Anaphylaxis

Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more rapidly-than IM epinephrine, as measured by clinical ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12151664/

First-in-class intranasal epinephrine spray for anaphylaxis

FMXIN002 4.0 mg nasal spray enables faster and higher epinephrine plasma absorbance at the short therapeutic window required for the treatment of anaphylaxis.

4.

nasuspharma.com

nasuspharma.com/nasus-pharma-announces-positive-clinical-results-of-recent-phase-2-study-with-fmxin002-intranasal-epinephrine-copy/

nasal powder epinephrine for the treatment of severe ...

FMXIN002 is an investigational intranasal epinephrine powder spray device that is noninvasive, needle-free, user-friendly, and reliable and ...

5.

jaci-inpractice.org

jaci-inpractice.org/article/S2213-2198(23)00709-2/fulltext

Fast Acting, Dry Powder, Needle-Free, Intranasal ...

FMXIN002, a dry powder intranasal epinephrine spray, is safe, fast absorbed, stable at room temperature, and needle free. However, it has not ...

6.

nasuspharma.com

nasuspharma.com/wp-content/uploads/2023/10/as-published-July-2023.pdf

A Promising Future Treatment for Anaphylaxis

FMXIN002, a dry powder intranasal epinephrine spray, is safe, fast absorbed, stable at room temperature, and needle free. However, it has not yet been ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213219823007092

Fast Acting, Dry Powder, Needle-Free, Intranasal ...

The FMXIN002 product offers a needle-free, pocket-size, safe, user-friendly, and stable alternative to epinephrine autoinjectors. Previous article in issue