(SOURCE: Bryn Pharma)
Bryn Pharma’s Experimental Anaphylaxis Treatment Continues to Show Promise
By Alex Keown
March 30, 2023
Privately-held Bryn Pharma’s experimental, intranasal form of epinephrine continued to show promise as a potential new treatment for anaphylaxis as the company is on the cusp of filing for FDA approval of Utuly.
The Raleigh-based company presented data at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) annual meeting that showed nasal congestion enhanced peak levels of epinephrine following intranasal administration of Utuly. The presentation from the study “The Effect of Nasal Congestion on the Bioavailability of Intranasally Administered Epinephrine in Healthy Adult Subjects with Seasonal Allergies,” showed a statistically significant increase in the intranasal absorption of epinephrine with congestion when compared to levels attained when dosed without congestion, the company announced.
Utuly is an investigational self-administered form of epinephrine being studied for the treatment of type 1 allergic reactions, including anaphylaxis.
If Bryn Pharma is able to bring Utuly to market, it will be the first novel delivery system for emergency epinephrine in fifty years. Currently, epinephrine is the only approved treatment for anaphylaxis, a life-threatening, whole-body allergic reaction to an allergen, a medical issue that is estimated to have impacted 5% of the U.S. population, according to the National Institutes of Health.
Additionally, the data showed treatment with Utuly demonstrated “higher and more sustained therapeutic plasma levels of epinephrine” when compared to the standard of care for anaphylaxis, the EpiPen autoinjector. The intranasal approach also provided an overall higher exposure compared to the EpiPen, the company announced.
Bryn Pharma’s data presented at ASCPT was from an open-label study conducted in 26 healthy adults with seasonal allergies. The study assessed multiple treatment levels. All treatments were well tolerated, the company reported.
David Dworaczyk, head of R&D, regulatory and production at Bryn Pharma, said the data was encouraging. Congestion is a common symptom during anaphylaxis and the study data indicates that Utuly is absorbed as quickly as medication delivered with an autoinjector. Not only that, Dworaczyk said Utuly provides a higher and more sustained exposure of epinephrine.
“The rapid attainment and sustained therapeutic levels of epinephrine are critical to optimize the successful treatment of anaphylaxis. This is an exciting advance for Utuly, and especially for the patient community that lives with severe food allergies and are seeking a needle-free alternative to autoinjectors,” Dworaczyk said.
Data shared at ASCPT follows similar positive Phase III data Bryn Pharma shared at the American Academy of Allergy, Asthma and Immunology earlier this year. In February, Bryn Pharma shared positive pharmacokinetic/pharmacodynamic data that showed when compared to standard of care, Utuly had a faster rate of absorption and a “higher or comparable acute and overall exposure,” the company reported. At the time, Bryn Pharma said Utuly was able to maintain epinephrine levels almost twice as long as standard of care.
“When it comes to treating anaphylaxis, time is of the essence. Delayed epinephrine administration or suboptimal exposure during anaphylactic events may increase the risk of hospitalizations and potentially fatal outcomes. There should be no hesitation in terms of treatment with rapid uptake,” Dworaczyk said. “This potentially negates the need for a second dose of epinephrine and gives patients more time to seek emergency medical attention.”
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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.
