epinephrine (BRYN-NDS1C) / Bryn Pharma - LARVOL DELTA

Impact of nasal congestion on intranasal rescue medication absorption and efficacy: A systematic review. (PubMed, Allergy Asthma Proc) - "Three additional studies that evaluated epinephrine, glucagon, and fentanyl found no effect of congestion on absorption. In the sixth study, congestion had no effect on zolmitriptan efficacy...Congestion may actually increase absorption of some intranasal epinephrine formulations. The impact of congestion on intranasal medication absorption is likely dependent on each drug's properties, mode of action, and formulation."

Journal • Review • Allergic Rhinitis • Immunology • Inflammation

Benefits of Epinephrine for Anaphylaxis Outweigh Potential Harm - A Safety Review. (PubMed, J Allergy Clin Immunol Pract) - "Appropriately dosed and administered epinephrine should engender no fear of use for anaphylaxis. The potential harm of delaying or withholding epinephrine treatment for anaphylaxis far outweighs the potential risk of AEs."

Adverse events • Journal • Allergy • Cardiovascular

Pharmacokinetic and pharmacodynamic profile of epinephrine nasal spray versus intramuscular epinephrine auto-injector in healthy adults. (PubMed, J Allergy Clin Immunol Pract) - "ENS rapidly achieved plasma epinephrine levels greater and more sustained than the IM auto-injector and with a similar PD effect."

Journal • PK/PD data

Randomized Trial of Pharmacokinetic and Pharmacodynamic Effects of 13.2 mg Intranasal Epinephrine Treatment in Congestion. (PubMed, Ann Allergy Asthma Immunol) - "13.2 mg ENS with congestion demonstrated enhanced absorption versus IM treatments and ENS without congestion and appeared well tolerated. There was no clinically impactful relationship between pharmacodynamic effects and plasma epinephrine concentration."

Journal • PK/PD data • Allergy • Immunology • Pain

Pharmacokinetics and Safety of Repeat Dosing with Epinephrine Nasal Spray in Healthy Adults (AAAAI 2024) - "A repeat dose of ENS within 5 minutes increases epinephrine absorption by approximately 50% with no notable effect on PD or safety compared with a single dose."

Clinical • Late-breaking abstract • PK/PD data

Pharmacokinetic Profile of Epinephrine Nasal Spray Versus Intramuscular Epinephrine Autoinjector in Healthy Adults (AAAAI 2024) - "The 13.2 mg ENS dose delivered in opposite nostrils or the same nostril rapidly achieved therapeutic levels of epinephrine that were maintained for longer than the 0.3 mg IM autoinjector. The ENS PK profile is comparable and non-inferior to IM autoinjector."

Clinical • PK/PD data • Dermatology

Pharmacodynamic Profile of Epinephrine Nasal Spray Versus Intramuscular Epinephrine Autoinjector in Healthy Adults (AAAAI 2024) - "The 13.2 mg ENS dose delivered in opposite nostrils or the same nostril had a pharmacological effect that was similar and non-inferior to the 0.3 mg IM autoinjector."

Clinical • PK/PD data • Dermatology

A 13.2 mg epinephrine intranasal spray demonstrates comparable pharmacokinetics, pharmacodynamics, and safety to a 0.3 mg epinephrine autoinjector. (PubMed, J Allergy Clin Immunol Glob) - "No serious or unexpected adverse events were reported, confirming results from earlier clinical studies. Bidose epinephrine spray addresses the unmet medical and patient needs for a needle-free, convenient, and effective dose-delivery system for self-administration of epinephrine that is as good as or better than the 0.3 mg autoinjector."

Journal • PK/PD data • Allergy • Food Hypersensitivity • Immunology

Mesa Science Associates and Bryn Pharma Publish Final of Three Pre-Clinical Studies of a New Approach to Treating Anaphylaxis (Yahoo Finance) - "Mesa Science Associates Inc. (MSA) and Bryn Pharma LLC published the findings from the final of three (3) pre-clinical studies conducted in beagle dogs...studies establish that epinephrine is readily absorbed when administered intranasally and has advantages over an intramuscular injection of epinephrine....The planned clinical studies will further investigate intranasal epinephrine pharmacokinetic and pharmacodynamic effects."

Preclinical • Allergy • Immunology

Bryn Pharma announces the publication of positive results from its intranasal epinephrine preclinical study program in three peer-reviewed scientific journals (PRNewswire) - "Bryn Pharma...today announced that a series of preclinical studies supporting the benefits of its BRYN-NDS1C needle-free device in the delivery of emergency epinephrine were recently published....Results from a preclinical study evaluating the nasal delivery of epinephrine in a preclinical canine congestion model...in the April 2020 edition of Respiratory Research....Second comparative pharmacokinetic (PK) study in a canine model...in the April 2020 edition of Pharmacology Research and Perspectives....A third preclinical study...in the May 2020 edition of Pharmaceutical Research."

Preclinical • Allergy • Immunology

Mesa science associates and Bryn Pharma publish preclinical study of a new approach to treating anaphylaxis (Yahoo Finance) - “Mesa Science Associates Inc. (MSA) and Bryn Pharma LLC published the findings from the first of three (3) pre-clinical studies conducted in beagle dogs. These studies establish that epinephrine is readily absorbed when administered intranasally and that the intranasal absorption of epinephrine is not altered in the presence of congestion….The study was funded by Bryn Pharma LLC of Raleigh, NC. The study was published in Respiratory Research….Anticipating the publication of the next two (2) studies within several months.”

Preclinical • Allergy • Immunology

Bryn Pharma presents data demonstrating comparable pharmacokinetic and pharmacodynamic effects of intranasal epinephrine to intramuscular epinephrine in adults (PRNewswire) - P1, N=95; "Bryn Pharma, LLC...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."

P1 data • PK/PD data