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NEW ORLEANS, Oct. 29, 2019 /PRNewswire/ -- Bryn Pharma, LLC ("Bryn" or the "Company"), a privately held pharmaceutical company dedicated to finding a better way for patients and caregivers to treat anaphylaxis, presented data from a preference study of its Bi-dose Epinephrine Nasal Spray versus EpiPen® Auto-Injector (EAI) in patients with severe allergies at the American Academy of Pediatrics (AAP) National Conference & Exhibition in New Orleans, LA. The results demonstrated that both EpiPen-experienced and EpiPen-inexperienced patients preferred Bryn's needle-free Bi-dose Epinephrine Nasal Spray over the EpiPen Auto-Injector across a series of key parameters, several described below:
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Question
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EAI-experienced
Patients
n=24
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EAI-inexperienced
Patients
n=32
|
|
Preference
for Bi-dose
ENS, n (%)
|
p value
|
Preference
for Bi-dose
ENS, n (%)
|
p value
|
|
Which device do you think you would be more likely to carry with you in daily life?
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18
(75.0%)
|
<.001
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27
(84.4%)
|
<.001
|
|
Which device is easier to use?
|
20
(83.3%)
|
<.001
|
26
(81.3%)
|
<.001
|
|
Which device do you prefer overall?
|
16
(66.7%)
|
<.001
|
27
(84.4%)
|
<.001
|
|
Which device do you prefer based on the size of the device?
|
23
(95.8%)
|
<.001
|
28
(87.5%)
|
<.001
|
"Market research has shown that there is an unmet need for more patient-friendly alternatives to traditional epinephrine auto-injectors," said David Dworaczyk, Ph.D., CEO of Bryn Pharma. "This study demonstrated a significant preference for Bryn's Bi-dose Epinephrine Nasal Spray across a number of metrics including portability, ease-of-use, safety, size and comfort."
About the Study
In a multi-center, randomized crossover preference study of Bi-dose Epinephrine Nasal Spray versus EpiPen Auto-Injector, preference was evaluated in an eight-question survey that was validated through a pilot study in advance of the testing. Fifty-six patients with severe allergies (27 pediatric patients and 29 adult patients) attended a one-on-one session to learn how to use both devices. All patients had been prescribed EpiPen Auto-Injector, but were only characterized as EpiPen-experienced if they had previously used an EpiPen Auto-Injector. After simulating use of an EpiPen Auto-Injector trainer and an empty Bi-dose Epinephrine Nasal Spray, patients responded to the forced-choice questionnaire which was designed based on differences between the EpiPen Auto-Injector and the Bi-dose Epinephrine Nasal Spray.
The assessment of preference was based on the following metrics: portability, ease of use, overall preference, willingness to recommend device, safety, size, use in a real emergency, and comfort using in public. Each question was analyzed separately for EpiPen-experienced participants (n=24) and EpiPen-inexperienced participants (n=32) with an exact binomial test using the binomial test function in R. A probability value (p=.05) was used to evaluate statistical significance.
To request a copy of the poster, please contact Daina Basile at dbasile@klcpr.com.
About the Clinical Development Program
Bryn has completed the pivotal clinical trial of its Epinephrine Nasal Spray (BRYN-NDS1C), using a single, portable, optimized device capable of delivering two therapeutic doses of epinephrine, replacing the need to carry two epinephrine auto-injectors.
About Anaphylaxis
Anaphylaxis is a serious, life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medication and latex.1 A major difference between anaphylaxis and other allergic reactions is that anaphylaxis typically involves more than one system of the body.2 Anaphylaxis requires immediate medical treatment, driving approximately 100,000 emergency room visits in the U.S. each year.1,3 Because 30 percent of patients who develop anaphylaxis will require a second dose of epinephrine to control symptoms, practice parameters recommend that physicians provide patients with two auto-injectors.4 If not treated properly, anaphylaxis can be fatal.2 However, studies have shown that the majority of people at risk for anaphylaxis often do not carry two epinephrine auto-injectors due in part to size and cost of the products, putting patients at greater risk of severe complications during an allergic reaction.
About Bryn Pharma
Bryn Pharma, founded in 2016, is a privately held pharmaceutical company founded by patients for patients. Bryn is focused on positively disrupting the existing market for epinephrine auto-injectors 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. BRYN-NDS1C is not currently approved for sale by the FDA or any international regulatory authority. For more information visit www.brynpharma.com.
EpiPen is a registered trademark of Mylan Inc.
Forward-Looking Statements
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties, such as risks related to product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company's products to patients, market and physician acceptance of the Company's products, intellectual property protection and competitive product offerings, could cause actual events to differ from the expectations indicated in these forward-looking statements. You are cautioned not to put any undue reliance on any forward-looking statement. This press release is neither an offer to sell nor a solicitation of an offer to purchase any particular securities. Any such offer or solicitation will be made only pursuant to definitive legal agreements prepared specifically for such purpose. An investment in the Company's securities entails significant risks and is suitable only for sophisticated investors who can afford a loss of their entire investment; no assurance can be given that investment objectives will be achieved. In considering the performance information contained herein, you should bear in mind that past performance is not necessarily indicative of future results; there can be no assurance that the Company will achieve comparable results or that any projected returns will be met. The Company does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
- American Academy of Allergy, Asthma & Immunology. Available at https://www.aaaai.org/conditions-and-treatments/allergies/anaphylaxis. Accessed on June 19, 2019.
- American Academy of Allergy, Asthma & Immunology. Available at: https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/anaphylaxis. Accessed on June 19, 2019.
- Fromer L. Prevention of Anaphylaxis: The Role of the Epinephrine Auto-Injector. Am J Med. 2016 Dec; 129(12): 1244-1250.
- Anaphylaxis – a practice parameter update 2015; Lieberman, Phillip et al.; Annals of Allergy, Asthma & Immunology, Volume 115, Issue 5, 341-384.
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SOURCE Bryn Pharma, LLC
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