People who live with food allergies demand more convenient, needle-free alternatives to EpiPen, like Bryn’s investigational epinephrine nasal spray

Bryn Pharma LLC, a privately held pharmaceutical company dedicated to finding a better way for patients and caregivers to treat anaphylaxis, is today celebrating the power of the food allergy advocacy community’s efforts to advance life-changing innovations. In September 2021, the U.S. Food and Drug Administration (FDA) partnered with the Food Allergy Collaborative to organize a Patient Focused Drug Development Day. The findings have now been published in the Voice of the Patient report.

The Voice of the Patient highlights the unmet needs of the food allergy community toward addressing life-threatening anaphylactic attacks, particularly in the outpatient setting. This includes an urgent need for an alternative to epinephrine autoinjectors and, specifically, a needle-free alternative to the current market leader, the EpiPen. The report concluded: “Patients are looking for a device that is better or comparable to an autoinjector but without a needle.”

“Bryn Pharma celebrates the findings shared in the Voice of the Patient report. As patients and caregivers ourselves, we are deeply familiar with and share these concerns. This report shines much-needed light into an industry that has had no significant innovation in decades, and calls into focus the daily burden of anxiety and fear faced by the allergy community. It’s time for new approaches that can help alleviate that burden,” said Michelle Lobel, Co-Founder and Chief Inspiration Officer of Bryn Pharma.

“Current outpatient treatments for anaphylaxis attacks are failing patients and families, causing hundreds of unnecessary deaths in the U.S. per year. Patients need a product that is easier to carry and easier to administer. More innovation toward needle-free alternatives that provide rapid absorption of epinephrine are needed immediately, and this new report shows that patients, parents and caregivers are demanding it,” said David Dworaczyk, Ph.D., CEO of Bryn Pharma.

“Bryn supports the food allergy community, as our mission has always been to bring to market an alternative outpatient delivery system providing patients the same pharmacokinetics as the epinephrine autoinjector, but without the needle,” said Michelle. “We are thrilled that the FDA has invited the patient community in as vital stakeholders and look forward to continuing our work to bring that new technology to market.”

The Proven Need for New Options

In addition to the emotionally compelling reasons for new options included in the Voice of the Patient report, published studies have explored the reasons behind why anaphylactic attacks are often untreated, or not treated rapidly. Research has shown that the most popular epinephrine treatment, autoinjectors, rely on needles, which many people fear or aren’t prepared to use.* An estimated 50% of those who are prescribed an autoinjector do not carry them due to size, and in response to an attack, 30% of those who carry it fail to use their autoinjector properly.* Further, 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.⁽¹⁾ These factors can lead to potentially deadly outcomes for allergy patients, and support the need for innovative new approaches.

Bryn recently announced the completion of its pivotal study of its investigational epinephrine nasal spray. The primary objective of the study was to evaluate whether the administration of the nasal spray 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).

About Bryn Pharma

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 visit www.brynpharma.com.

*Bryn Market Research – data on file.

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“Patients are looking for a device that is better or comparable to an autoinjector but without a needle.” - Voice of the Patient Report