Bryn Pharma, 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:
| Question | EAI-experienced
Patients n=24 |
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? | 18
(75.0%) |
<.001 | 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.
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.
Source: Company Press Release
