Bryn Pharma Presents Data Demonstrating Comparable Pharmacokinetic and Pharmacodynamic Effects of Intranasal Epinephrine to Intramuscular Epinephrine in Adults

RALEIGH, N.C., April 6, 2020 /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 through its development of a unique bi-dose nasal epinephrine product, today announced the availability of a poster presenting compelling data from a large, two-part, Phase I clinical study in healthy adults. Results from the study demonstrated that intranasal (IN) delivery of epinephrine from Bryn's needle-free Bi-dose Epinephrine Nasal Spray is comparable to intramuscular (IM) injection in pharmacokinetics, pharmacodynamics, and safety. The late-breaking poster, originally slated for presentation at the American Academy of Asthma, Allergy and Immunology (AAAAI) Annual Meeting on March 15, 2020 is now available on the AAAAI website following cancellation of the national conference. 

"This study supports the possibility that intranasal epinephrine may offer an effective alternative route of administration for the treatment of anaphylaxis," said Dr. Phillip Lieberman, M.D., Clinical Professor of Medicine and Pediatrics in the Departments of Internal Medicine and Pediatrics (Divisions of Allergy and Immunology) at the University of Tennessee College of Medicine.

David Dworaczyk, Ph.D., CEO of Bryn Pharma added, "The study demonstrated that intranasal epinephrine delivered through a bi-dose nasal spray is a potentially novel therapeutic option in anaphylactic treatment, which may allow patients to replace two auto-injectors with a single nasal device. This is a critical benefit to patients and caregivers in an emergency environment because 30% require a second dose to provide adequate treatment to a patient in anaphylaxis."

About the Study
The Phase I, open-label, two-part comparative bioavailability study compared the pharmacokinetics and pharmacodynamics of epinephrine administered IN and IM in 95 healthy male and female participants 19-45 years of age (Part 1 n=55; average age 33 ± 6) (Part 2 n=40; average age 31 ± 7). 

Part 1 was conducted as a randomized, 3-treatment, 5-period, semi-replicate design and consisted of single doses of IN epinephrine (6.6 mg), IM epinephrine (0.3 mg) via EpiPen^® and IM epinephrine (0.5 mg) via manual syringe. Part 2 was conducted as a randomized, 3-treatment, 3-period crossover design conducted in parallel with Part 1. Participants in Part 2 received 2 doses, 5 minutes apart, of IN epinephrine (6.6 mg in opposite nostrils), IN epinephrine (6.6 mg in the same nostril), IM epinephrine (0.3 mg in opposite thighs). Blood samples were collected at specific intervals to measure plasma epinephrine.

Key Study Findings
Pharmacokinetics (PK)

• Two IN epinephrine doses in the same nostril (IN epinephrine 2 x 6.6 mg) led to increased epinephrine absorption versus 2 IN epinephrine doses in the opposite nostril (IN epinephrine 2 x 6.6 mg).
• Two IN epinephrine doses in the same or opposite nostrils led to substantially greater epinephrine absorption versus a single dose of IM epinephrine (0.3 mg).            
• Two IN epinephrine doses in the same nostril (IN epinephrine 2 x 6.6 mg) led to increased epinephrine absorption versus 2 doses of IM epinephrine (0.3 mg) in the opposite legs (IM epinephrine 2 x 0.3 mg).
• At most time points, a greater percentage of participants achieved epinephrine concentrations of between 100 and 200 pg/mL after 2 IN epinephrine doses in the same nostril (IN epinephrine 2 x 6.6 mg) compared with a single dose of IM epinephrine (0.3 mg). 

Pharmacodynamics (PD)/Tolerability

• There were no clinically significant differences in heart rate or blood pressure after dosing of IN and IM epinephrine.
• Epinephrine IN was safe and well-tolerated in both study parts.
• The most common adverse event (AE) reported after IN epinephrine was nasal discomfort while the most common AEs after IM epinephrine administration were pain in extremity (IM epinephrine 0.3 mg and 0.5 mg) and tremor (IM epinephrine 2 x 0.3 mg).

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% 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.

EpiPen is a registered trademark of Mylan Inc.

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.

SOURCE Bryn Pharma, LLC