13.2mg Intranasal Epinephrine Spray Demonstrates Comparable PK/PD and Safety to 0.3mg Epinephrine Autoinjector
Our Product
We are developing a revolutionary epinephrine nasal spray for patients at-risk of anaphylaxis. Our clinical program focuses on efficacy and safety comparisons to the most widely prescribed outpatient treatment1, the 0.3 mg IM epinephrine autoinjector, in accordance with clinical practice guidelines.
Published Studies
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
Results from dose ranging pharmacokinetic and pharmacodynamic effects of nasal spray epinephrine versus autoinjector epinephrine in healthy participants
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.
Results from Bryn Pharma preclinical canine study presented at ACAAI National Conference
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.
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
Bryn Pharma publishes promising results from study assessing pharmacokinetic and pharmacodynamic effects of intranasal epinephrine versus intramuscular epinephrine
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.
Bryn Pharma healthcare professional study reveals significant preference for bi-dose intranasal epinephrine spray
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.
Bryn Pharma releases promising patient perspective results from preference study
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.
Our Device
We are developing an affordable, needle-free, small, and easy to use epinephrine nasal spray for the treatment of anaphylaxis. Studies have shown that, despite practice and prescription guidelines, most people at risk for anaphylaxis don't always carry one of their autoinjectors, and even fewer carry two epinephrine autoinjectors. This is due in part to size and cost of the products, putting patients at greater risk of severe complications during an allergic reaction. UTULY™ is designed to provide patients with a life-saving treatment that is affordable, needle free, small, easy to use and complies with practice parameters.
UTULY™ is not currently approved by the FDA or any international regulatory authority.
UTULY™, the brand name, is conditionally approved by the FDA.
