What is Anaphylaxis

A New Approach to Delivering Epinephrine May Help Deliver Better Patient Outcomes

The Rise of Anaphylaxis in the United States

Anaphylaxis is a growing problem in the United States. With its widespread prevalence and increasing incidence, it is a serious, potentially fatal allergic reaction with a rapid onset that requires early intervention. The rate of occurrence of anaphylaxis in the general population is increasing, especially in people in their first 20 years of life. The lifetime prevalence of anaphylaxis is between 1.6% and 5.1% of the US population, based on the current 2023 US population; this would equate to 5-17 million persons at risk, although some estimates are as high as 49 million1. There was a 32% increase in the incidence of reported anaphylaxis when comparing 2004–2007 rates with 2008-2016.

Medications and stinging insects are the leading triggers in adults, while foods and stinging insects are the most common triggers in children and adolescents. Food allergy impacts 8%–11% of children and adults in the US, while adverse drug reactions affect up to 10% of the world’s population. Anaphylactic reactions are triggered most commonly by medications (35%), food (32%), insects (19%), latex (3.1%), and unknown causes (11%). Perhaps more staggering is that ER visits for anaphylactic food reactions grew 377% from 2007-162. Only half of patients who experienced an anaphylactic event have been prescribed epinephrine3, and the majority of patients have poor carry rates and refill rates4

The Unmet Need

The first Epinepherine Auto Injector was approved in 1987. Unfortunately, innovation has been limited until recently and the epinephrine market is primed to move from needle to nasal. Epinephrine Auto-injectors elicit concern, anxiety, and discomfort among children, caregivers, and adults, which results in barriers to use. The most common barriers are affordability, fear of administration, social stigma and embarrassment and portability.

Now Carrying

55-60%4 of patients do not carry their epinephrine all of the time. Only 67% carry "most of the time"

Delay or Do Not Treat

Up to 50%5,6 patients delay treatment. 25-50%6 of patients do not administer. Needle delivery is main barrier

Do not have 2nd Device

Up to 30%7 of patients require a second injection. Majority of patients only carry 1 autoinjector

Treating anaphylaxis early is important, but patients often do not carry their epinephrine, do not administer, or delay use which increases the risk of a severe attack. Delaying timely epinephrine administration has been associated with poor outcomes and increased cost9-12. There are ~100,000 yearly ED visits due to anaphylaxis8. When epinephrine is administered prior to ED arrival, the likelihood of hospital admission is reduced significantly9. In fact, the mean total cost of an anaphylaxis related hospitalization is project to approach $24,000 in 201913

Bryn Pharma

References: 1. Wood et al. Anaphylaxis in America. JACI. 2014. 2016;129(12):1244–1250. 2. Food allergy in the United States: Recent trends and costs---An analysis of private claims data. FARE Health White paper, Nov 2017 3. website: Foodallergy.org, FARE Blog. Dec 12, 2022 4. Warren, C. et al. (2018) Ann. Allergy Asthma Immunol. 121(4): 479-491 5. Bryn Patient Research (N=202) 6. Bryn Market Research 7. Lieberman P et al. Ann Allergy Asthma Immunol . 2015;115:341 384. 8. Bryn Pharma Data on File 9. Fleming JT et al. J Allergy Clin Immunol Pract. 2015;3(1):57-62 10. LindorRA et al. West J EmergMed. 2018;19(4):693-700. 11. Tsai G et al. Allergy Asthma ClinImmunol. 2014;10(1):39. 12. Nowak R et al. J EmergMed. 2013;45(2):299-306. 13. CandrilliS et al. Value Health. 2015;18(7):A503.

In accordance with 35 U.S.C. § 287(a), the following list identifies Bryn's rights in U.S. patents associated with the NDS1C. This list may be a subset of Bryn's rights in U.S. patents directed to this product.

U.S. Patent No. 10,688,044
U.S. Patent No. 10,925,841
U.S. Patent No. 11,000,489