RALEIGH, NC, February 27, 2021 / PRNewswire / – Bryn Pharma, LLC (“Bryn” or “Company”), a private pharmaceutical company dedicated to finding a better way for patients and carers to treat anaphylaxis, was announced today positive clinical results from their multidose study. of BRYN-NDS1C (two-dose nasal spray epinephrine). Results from the study showed that administration of epinephrine with a single spray / dosing from Bryn’s two-dose nasal spray device resulted in a favorable solution profile with short- and long-term pharmacokinetic (PK) results that were comparable to or greater than the ones seen. administered by single self-injection epinephrine 0.3 mg. No safety issues were observed and no adverse or unexpected adverse events occurred with either intranasal (IN) or intramuscular (IM) dosing.
Full results from the late poster were unveiled today at the prestigious annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) 2021. An abstract of the study is published in the February 2021 online development to The Journal of Allergy and Clinical Immunology, and the poster display is available online.
“These clinical results show that one injection from our two-dose nasal spray machine administered epinephrine at levels equal to or higher than those administered by a single 0.3 mg epinephrine self-injection , which may allow patients to replace one nasal injection device with a single nasal device. , “he said David Dworaczyk, Ph.D., President of Bryn Pharma. “Up to 30% of patients receiving an anaphylactic event require a second dose of epinephrine, and our two-dose nasal spray device meets this essential need along with other benefits. including needleless delivery, ease of use and carrying capacity. We will continue to work diligently to complete the remaining necessary steps to obtain FDA approval. ”
About the Study
The open-label randomized, 5-treatment, 5-way crossover study compared pharmacokinetics of intranasal (IN) and intramuscular (IM) epinephrine administration in 25 healthy adults aged 19–45 years. Epinephrine administrations were as follows: 6.6 mg IN (1 x 6.6 mg), 4.4 mg IN (2 x 2.2 mg), 8.8 mg IN (2 x 4.4 mg), 13.2 mg IN (2 x 6.6 mg), and 0.3 mg IM (1 x 0.3 mg). Epinephrine concentrations and cardiovascular effects were measured (3030–360 min). PK Parameters (AUC)0-10, AUC0-20, AUC0-30, AUC0-60, AUC0-360, C.max (10 min), C.max; ANOVA) analysis and safety were assessed. Epinephrine bioavailability and adverse PK data showed that 6.6 mg IN epinephrine was the same compared to or greater than 0.3 mg IM self-injecting epinephrine, with pharmacodynamic effects associated with epinephrine. Other key findings from the inspection were as follows:
- At most time points, a relative percentage of participants reached epinephrine plasma concentrations of 100 and 200 pg / mL at peak point times after IN Bryn administration compared with IM administration.
- There were no clinically significant differences in heart rate or blood pressure after administration of epinephrine IN or IM
The researchers in the study concluded that Bryn’s two-dose nasal spray is a modern therapeutic option in the treatment of anaphylaxis that allows patients to easily administer a second dose if the first dose is not reduced. symptoms.
Two-dose BRYN-NDS1C Nasal Epinephrine Spray
Bryn Pharma Bi-dose Epinephrine Nasal Spray (BRYN-NDS1C) is a single, portable, needle-free device capable of delivering two therapeutic doses of epinephrine, ensuring adherence to clinical guidelines while in place of the need to carry two epinephrine injections. The two therapeutic doses contained in each two-dose IN device provide confirmation that a second dose is readily available if another dose is required for symptom control, an urgent need that occurs in 30% of doses. patients undergoing an anaphylactic event. In early 2019, the U.S. Food and Drug Administration (FDA) granted the BRYN-NDS1C Fast Track Designation. The Company has completed three human clinical trials of BRYN-NDS1C and has deployed a commercial 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.
About Anaphylaxis
Anaphylaxis is a life-threatening severe allergic reaction. The most common anaphylactic reactions are to foods, insecticides, medications and latex.1 A key difference between anaphylaxis and other allergic reactions is that anaphylaxis usually 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 Since 30% of patients who develop anaphylaxis need a second dose of epinephrine to control symptoms, paramedics suggest that physicians give patients two automatic injections.4 If not treated properly, anaphylaxis can be fatal.2 However, studies have shown that most people at risk for anaphylaxis often do not carry two epinephrine injections due in part to the size and cost of the products, putting patients in increased risk of serious complications during an allergic reaction.
About Bryn Pharma
Bryn Pharma is a privately held pharmaceutical company that established patients for patients. Bryn aims to positively tap the existing market for epinephrine self-injection by delivering an affordable, easy-to-use option that better meets the needs of patients. Bryn Pharma is trying to get the growing population at risk for anaphylaxis with A Better Way to be prepared for a life – threatening sensory reaction. For more information, visit www.brynpharma.com.
Forward-looking statements
Statements made in this press release are forward looking in time or express beliefs, expectations or hopes regarding future events or expected results or benefits such as positive statements. Various risks and uncertainties, such as risks related to product development and commercialization efforts, clinical trial results, final clinical results and the benefit of the Company’s products to patients, market and physician acceptance of the Company’s products, protection of intellectual property and competitive output of tenders, the actual events of which may differ from what was expected in these forward-looking statements. You are cautioned not to rely heavily on any positive comment. This press release is not an offer to sell or a bid for an offer to purchase any specific securities. Such an offer or application shall be made only in accordance with definitive legal agreements specifically prepared for that purpose. Investing in the Company’s securities involves significant risks and is only suitable for solemn investors who are able to lose their entire investment; no guarantee can be given that investment objectives will be met. In considering the performance information contained herein, you should bear in mind that past performance is not an indication of future results; it cannot be guaranteed that the Company will achieve comparable results or that any estimated results will be achieved. The Company accepts no obligation to update or publicly review 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 21 December 2020.
- American Academy of Allergy, Asthma & Immunology. Available at: https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/anaphylaxis. He will be reached 21 December 2020.
- Fromer L. Prevention of Anaphylaxis: The Role of the Epinephrine Auto-Injector. Am J Med. December 2016; 129 (12): 1244-1250.
- Anaphylaxis – 2015 use parameter update; Lieberman, Phillip et al .; History of Anne Allergy, Asthma & Immunology, Volume 115, Issue 5, 341-384
SOURCE Bryn Pharma, LLC
Related Links
http://www.brynpharma.com