Bryn Pharma Announces Completion of its Pivotal Study Comparing UTULY Epinephrine Intranasal Spray Versus 0.3-mg Epinephrine Autoinjector for the Treatment of Anaphylaxis
Bryn Pharma LLC recently announced the completion of its pivotal study of UTULY (epinephrine nasal spray). The primary objective of the study was to evaluate whether the administration of UTULY could achieve a successful release profile with both short- and long-term pharmacokinetic (PK) and pharmacodynamic (PD) outcomes comparable to those seen with administration of the 0.3-mg epinephrine autoinjector (EpiPen, generic). Bryn intends to present study results at upcoming medical conferences.
Epinephrine autoinjectors are the most widely prescribed treatment in the outpatient setting for anaphylaxis. While effective, autoinjectors have several limitations, including cost, fear of needles and convenience, leading people to avoid carrying the recommended two autoinjectors. This puts patients at greater risk of severe complications during an allergic reaction.
“We are extremely encouraged with the results from our pivotal study comparing the needle-free UTULY nasal spray to the 0.3-mg IM autoinjector. Our findings have given us the confidence to move forward in the regulatory process. We are thrilled to be one step closer to improving the lives of people who live in fear of life-threatening allergic reactions and who are looking for alternatives to costly and cumbersome autoinjectors,” said David Dworaczyk, PhD, CEO of Bryn Pharma.
“Completion of this study is a key milestone in the evolution of the treatment for anaphylaxis. Our hope is that the clinical trial results from Bryn’s innovative nasal product will support UTULY as an effective, safe and practical alternative to autoinjectors,” said Melinda Braskett, MD, Associate Medical Director of the Gores Family Allergy Center at Children’s Hospital Los Angeles, and Bryn Pharma Scientific Advisor.
Anaphylaxis is a serious, life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medication and latex. A major difference between anaphylaxis and other allergic reactions is that anaphylaxis typically involves more than one system of the body. Estimates of Americans at risk for anaphylaxis range from 3.29 million to 40.9 million. Early and fast administration of epinephrine (with quick uptake) using today’s most common method of delivery, the autoinjector (as opposed to a manual syringe which is used in a medical setting under the direct supervision of a doctor), is deemed critical to bringing the anaphylactic reaction under control. Because 30% of patients who develop anaphylaxis will require a second dose of epinephrine to control symptoms, practice parameters recommend that physicians provide patients with two autoinjectors.
If not treated properly, anaphylaxis can be fatal. However, studies have shown that the majority of people at risk for anaphylaxis often do not carry two epinephrine autoinjectors due in part to size and cost of the products, putting patients at greater risk of severe complications during an allergic reaction.
Bryn Pharma, established in 2017, is a privately held pharmaceutical company founded by patients for patients. Bryn is focused on positively disrupting the existing market for epinephrine autoinjectors by delivering an accessible, easy-to-use alternative that better meets the needs of patients. Bryn Pharma seeks to provide this growing population at risk for anaphylaxis with A Better Way to be prepared for a life-threatening allergic reaction. For more information, www.brynpharma.com.
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