RALEIGH, N.C., Jan. 4, 2021 /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, today announced that results from its multi-dose study of BRYN-NDS1C (bi-dose epinephrine nasal spray), have been accepted for presentation at the 2021 American Academy of Asthma, Allergy and Immunology (AAAAI) annual meeting to be held virtually February 26 to March 1, 2021. The study presentation will highlight the favorable release profile, pharmacokinetic and pharmacodynamic outcomes of epinephrine when administered with one spray from Bryn's two-dose nasal spray device as compared to those seen with administration by a single 0.3 mg epinephrine auto-injector. Presentations will be available to attendees via the conference website.
"We are very encouraged by the findings from our multi-dose study comparing the bioavailability and cardiovascular effects of a single spray from our bi-dose nasal device with a single 0.3 mg auto-injector and look forward to sharing the results with the allergy community," said David Dworaczyk, Ph.D., CEO of Bryn Pharma. "Our goal at Bryn Pharma is to provide patients at risk for anaphylaxis the advantages inherent in our small nasal spray, including its easy use and carry design, needle-free delivery, and the convenience of two doses of drug within a single device. We look forward to completing the remaining steps required to gain FDA approval."
BRYN-NDS1C Bi-Dose Epinephrine Nasal Spray
Bryn Pharma's Bi-dose Epinephrine Nasal Spray (BRYN-NDS1C) is a single, portable, needle-free device capable of delivering two therapeutic doses of epinephrine, ensuring compliance with clinical guidance while replacing the need to carry two epinephrine auto-injectors. The two therapeutic doses contained in each of our bi-dose devices provides assurance that a second dose is readily available if another dose is needed for symptom control, a critical need that occurs in 30-40% of patients experiencing an anaphylactic event. In early 2019, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BRYN-NDS1C. The Company has completed three human clinical studies of BRYN-NDS1C and has put in place a commercial-scale, high-speed manufacturing line in preparation for the anticipated market launch. BRYN-NDS1C is not currently approved for sale by the FDA or any international regulatory authority.
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% 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. For more information visit www.brynpharma.com.
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.
1. American Academy of Allergy, Asthma & Immunology. Available at https://www.aaaai.org/conditions-and-treatments/allergies/anaphylaxis. Accessed on December 21, 2020.
2. American Academy of Allergy, Asthma & Immunology. Available at: https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/anaphylaxis. Accessed on December 21, 2020.
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
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