Clinical Development

Bryn Pharma is developing an affordable, needle-free, small, easy to use epinephrine nasal spray as an alternative to current epinephrine autoinjectors for the treatment of anaphylaxis. Our clinical program focused on demonstrating comparable or improved pharmacokinetic parameters and safety comparisons of NDS1C to the current standard of care treatment, the 0.3 mg IM autoinjector, in accordance with clinical practice guidelines.

Bryn Pharma is addressing the current treatment gaps in Anaphylaxis that include:

  • Most patients who are at risk for anaphylaxis do not carry their autoinjectors regularly.
  • Patients need an easy-to-carry device that is manageable, not too big nor too bulky, to ensure they have it with them at all times for use when necessary.
  • Many patients are afraid to inject themselves because of the anxiety, stress, and fear of the needle, causing a delay in treatment.

Our Science

The results have demonstrated that with a single dose of NDS1C, its PK release profile is comparable to the standard reference product, the 0.3 mg IM autoinjector, and a more rapid uptake than the manual syringe, especially in the critical acute phase of an anaphylactic event, i.e., the first 20-minutes. In addition, the data clearly demonstrate that NDS1C is safe: across the entire clinical development program, there have been no serious or unexpected adverse events.

Pharmocokinetic and Heart Rate Study
Nasal Congestion Study
Dosing Crossover Study
Innovations in the treatment of anaphylaxis
Crossover Study to Compare the PK of Intranasal and IM Epinephrine

Pre-Clinical Studies (Canine)

Intranasal epinephrine in dogs: Pharmacokinetic and heart rate effects

Overall, IN epinephrine demonstrated advantages over IM epinephrine, including the rapid increase in plasma epinephrine and lack of increased heart rate over time.

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Results from a canine study on pharmacokinetics and heart rate effects

Bryn Pharma recently released more clinical data in Pharmacology Research & Perspectives. The study examined pharmacokinetic and heart rate effects of Bryn Pharma's intranasal (IN) epinephrine versus intramuscular (IM) injection. This comparative study was performed in a canine model.

Results from the study were released on April 17, 2020. Overall, IN epinephrine demonstrated advantages over IM epinephrine, including rapid increase in plasma epinephrine and lack of increased heart rate over time.

Click to view the full study at Pharmacology Research & Perspectives

Results from Bryn Pharma preclinical canine study presented at ACAAI National Conference

Nasal Congestion Study Poster Screenshot

At the 2019 American College of Allergy, Asthma & Immunology National Conference (ACAAI) in Houston, Bryn Pharma presented findings from their preclinical study assessing intranasal epinephrine effects on pharmacokinetics and heart rate in a nasal congestion canine model. The full manuscript of the study was released in Respiratory Research on April 3, 2020.

In the study, intranasal epinephrine entered the blood plasma even in the presence of nasal congestion.

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Click to view the full study at Respiratory Research

Innovations in the treatment of anaphylaxis: A review of recent data

This review explores innovative nasal and oral products under investigation for the outpatient emergency treatment of anaphylaxis.

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5-Period, 5-Treatment Crossover Study to Compare the Pharmacokinetics of Intranasal and Intramuscular Epinephrine Administration in Healthy Adult Participants

AAAI Study

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Dose Confirmation Study
Nasal Congestion and Exposure of Epinephrine Intranasally

Pivotal Studies (13.2 mg intranasal dose)

13.2 mg Intranasal epinephrine treatment in congestion shows increased bioavailability without pharmacokinetic and pharmacodynamic correlation

ACAAI 2023 Poster

13.2mg epinephrine nasal spray (ENS) in congestion demonstrated enhanced absorption vs. IM treatment and 13.2 mg ENS without congestion

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Comparative Delivery Study
Dosing Crossover Study
Self-Administration Study

Supportive Studies

Bryn Pharma publishes promising results from study assessing pharmacokinetic and pharmacodynamic effects of intranasal epinephrine versus intramuscular epinephrine

Comparative Delivery Study Poster Screenshot

The Bryn Pharma team recently released an open-label, 2-part comparative bioavailability study to compare pharmacokinetic and pharmacodynamics after epinephrine intranasal (IN) or intramuscular (IM).

Results included comparative measures. Two epinephrine doses in the same nostril led to increased epinephrine absorption versus 2 IN doses in opposite nostrils and 2 IM doses;2 epinephrine doses in the same or opposite nostrils led to substantially greater epinephrine absorption vs 1 epinephrine IM dose. Epinephrine IN was also found to be safe and well-tolerated.

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Results from dose ranging pharmacokinetic and pharmacodynamic effects of nasal spray epinephrine versus autoinjector epinephrine in healthy participants

AAAI 2021 Dose Ranging Study Poster Screenshot

Bryn Pharma presented their findings from a 5 Period, 5-way crossover study during a virtual meeting at the American Academy of Allergy, Asthma & Immunology.

Results suggested that the bi-dose nasal spray may produce a more favorable epinephrine exposure profile and alleviation of anaphylactic symptoms as compared with the autoinjector.

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Subanalysis of an open-label, crossover study to assess the relative bioavailability of self-administered nasal epinephrine compared to administration by trained health personnel in healthy adult subjects

AAAI 2021 self addministration poster

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HCP Preference Study
Patient Preference Study

Human Factors

Bryn Pharma healthcare professional study reveals significant preference for bi-dose intranasal epinephrine spray

HCP Preference Study Poster Screenshot

In November 2019, Bryn Pharma released the results of a multicenter, randomized crossover healthcare professional preference study between the EpiPen® auto-injector and the bi-dose intranasal epinephrine spray. These results were presented at the American College of Allergy, Asthma & Immunology National Conference (ACAAI), taking place November 7–11, in Houston, TX.

Results from the study show significant preference in 56 healthcare professionals for the bi-dose epinephrine nasal spray over the EpiPen® auto-injector based on an array of assessments.

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Bryn Pharma releases promising patient perspective results from preference study

Patient Preference Study Poster Screenshot

In October 2019, Bryn Pharma released the results of a multicenter, randomized crossover patient preference study between the EpiPen® auto-injector and the bi-dose epinephrine nasal spray were presented at the American Academy of Pediatrics (AAP) National Conference in New Orleans, LA.

Results from the study show patients’ significant preference for the bi-dose epinephrine nasal spray over the EpiPen® auto-injector on various metrics including comfort, ease of use, portability, and overall preference. The study assessed other preference factors as well.

Click here to access the full poster