Bryn Pharma Completes Dosing in Pivotal Clinical Trial Designed to Support U.S. Approval of Intranasal Epinephrine Spray

RALEIGH, N.C., Oct. 10, 2019 /PRNewswire/ -- Bryn Pharma, LLC ("Bryn") is a privately held pharmaceutical company dedicated to finding a better way for patients and caregivers to treat anaphylaxis. Bryn has developed an epinephrine nasal spray, a disruptive innovation designed to replace the currently approved epinephrine auto-injector. Over the last three years, Bryn has conducted extensive preclinical and clinical trials of its Intranasal Epinephrine Spray (BRYN-NDS1C), which is easy-to-use, needle-free and completely portable. Bryn's novel intranasal drug delivery device has already been approved for use in other indications by the U.S. Food and Drug Administration (FDA).

In early 2019, the Company submitted an Investigational New Drug (IND) application for BRYN-NDS1C with the FDA and was granted Fast Track Designation. Bryn has successfully completed the required Pilot Studies and has completed dosing in its Pivotal Clinical (human) Trial.

"We are pleased to report that Bryn's clinical development program for BRYN-NDS1C has met all milestones to-date," said David Dworaczyk, Ph.D., CEO of Bryn Pharma. "The product demonstrated comparable pharmacokinetics to an intramuscular injection of epinephrine in our Pilot Clinical (human) studies. We are looking forward to the results of our Pivotal Trial shortly."

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 market for the currently approved epinephrine auto-injectors by delivering an accessible, easy-to-use alternative that better meets the needs of patients. Up to 49 million Americans may have food allergies and suffer anaphylaxis, and that number is increasing annually. Bryn Pharma seeks to provide this growing patient population 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.

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

1. American Academy of Allergy, Asthma & Immunology. Available at https://www.aaaai.org/conditions-and-treatments/allergies/anaphylaxis. Accessed on June 19, 2019.

2. American Academy of Allergy, Asthma & Immunology. Available at: https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/anaphylaxis. Accessed on June 19, 2019.

3. Fromer L. Prevention of Anaphylaxis: The Role of the Epinephrine Auto-Injector. Am J Med. 2016 Dec; 129(12): 1244-1250.

4. Anaphylaxis – a practice parameter update 2015; Lieberman, Phillip et al.; Annals of Allergy, Asthma & Immunology, Volume 115, Issue 5, 341-384.

SOURCE Bryn Pharma, LLC