FREDERICK, MD April 13, 2020—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. In fact, the absorption of epinephrine was enhanced in the histamine-induced congestion model when compared to a non-congestion model. The pre-clinical study was managed by MSA and was conducted at MRI Global Laboratories in Kansas City, MO. The study was funded by Bryn Pharma LLC of Raleigh, NC. The study was published in Respiratory Research and is entitled Intranasal epinephrine effects on epinephrine pharmacokinetics and heart rate in a nasal congestion canine model.
Anaphylaxis is a serious and sometimes life-threatening allergic reaction where the immune system overreacts to an allergen by releasing histamines that cause allergy symptoms. In severe cases if anaphylaxis isn’t properly treated, it can be fatal. Rates of such reactions have increased over the last 20 years and are usually treated by administering epinephrine into a muscle with an auto-injector.
The study offered an alternate route of administration for epinephrine, via the nose, reducing the anxieties that come along with auto-injector use. A device containing epinephrine for nasal administration can offer convenience with its small size by being easier to carry and is noninvasive when compared to the intramuscular injection involved with the auto-injector. Intranasal administration of epinephrine could lead to increased usage versus an auto-injector, with less hesitation for use in patients with severe allergies.
The study focused on evaluating whether changes in the nasal environment, such as congestion produced by histamines, could influence the absorption of the drug. The study compared the rate and amount of epinephrine absorbed via the nasal cavity in a canine model of congestion produced by the local administration of histamine compared to non-congestion control subjects.
This research found that epinephrine was absorbed more rapidly and in greater amounts over 90 minutes in the presence of histamine-produced congestion as compared to non-congested subjects. One of the routine effects observed with epinephrine is an increase in heart rate. The study found that heart rate increases were greater in the congestion model, which correlated with the greater absorption of epinephrine. It should be noted that during the conduct of these studies no animals were injured, and all of the study dogs were adopted into forever homes.
Michael Mesa, CEO of Mesa Science Associates, is anticipating the publication of the next two (2) studies within several months. These pre-clinical studies preceded human studies which were started in 2019 and are planned for completion over the coming summer.
In addition to the pre-clinical studies, MSA continues to provide support for Bryn Pharma nasal product development activities including device activities, identification of a contract fill and finish source, and coordination with the fill and finish source for Chemistry, Manufacturing and Controls activities. MSA also utilizes its extensive list of pharmaceutical experts to provide advice on a variety of manufacturing, quality, technical and scientific issues.
Mesa Science Associates is a pharmaceutical product development company located inside the Frederick Innovation and Technology Center Inc. (FITCI) in Frederick, MD. The mission of the company is to provide technical and scientific expertise to researchers from all aspects of the drug, drug delivery and product development community, including researchers from government, academia, as well as private entities.
For more information on Mesa Science Associates visit https://www.mesascience.com/
Contacts
Michael Mesa
240-778-8616
FITCI – officemanager@fitci.org
