For some people, many foods, medicines, and bee stings mean life-threatening allergic reactions that require immediate treatment with injectable epinephrine. For many people, January means the start of a new drug deductible to be met. In June 2017 the FDA approved a new form of emergency epinephrine called Symjepi, which may be good news for people who must be prepared in the event of a life-threatening allergic reaction.
The seriousness of a severe allergic reaction
Severe allergic reactions affect anywhere from 5% to 70% of persons, depending on age and prior exposure. Anaphylactic or “type 1” (immediate hypersensitivity) reactions are the most severe forms of allergic reaction to a substance: insect venom, foods, or some drugs. People who have had prior exposure to an allergic substance are “sensitized” and when they are re-exposed, can have a reaction within seconds to minutes. Anaphylactic reactions are caused by the release of histamine and other chemicals throughout the body, resulting in leaky blood vessels that contribute to swelling of tissues in the mouth and airway and very low blood pressure. These symptoms can lead to difficulty swallowing and speaking, wheezing and severe shortness of breath, and death.
Treating severe allergic reactions
The treatment for severe allergic reactions is the administration of epinephrine (adrenaline) at the first sign of symptoms. Epinephrine is one of the chemicals in the body that raises blood pressure and heart rate. Epinephrine can be administered through an IV in the hospital, but since the 1980s, epinephrine has been available as a pre-filled syringe that can be obtained with a prescription and immediately injected into the thigh muscle when severe allergic symptoms are recognized.
The prevalence of severe allergies has been increasing since 2000. Anaphylaxis to some external chemical or allergen occurs in 2% of the population, and it is estimated that approximately 500 people die from anaphylactic reactions per year in the US. Because of this, more and more people need to have epinephrine available wherever they are (home, school, when traveling). So it is no surprise that the manufacture and marketing of pre-filled epinephrine syringes has been big news in the last two years.
Keeping epinephrine at the ready
Spring-loaded autoinjectors that contain epinephrine have been manufactured by several companies since 1987. In the last 30 years, changes in pharmaceutical companies and patent transfers resulted in a near-monopoly in the production of pre-filled epinephrine products. From 2009 to 2016, one company with a 90% market share dramatically increased the consumer cost for epinephrine injectors, resulting in an investigation and eventual settlement with the US Department of Justice.
Although not a spring-loaded autoinjector, Symjepi consists of two single-dose, pre-filled syringes of epinephrine, for the emergency treatment of anaphylactic and severe allergic reactions in adults. Each pre-filled syringe contains 0.3 mg epinephrine, the recommended initial dose for emergency treatment of anaphylaxis.
At an anticipated lower cost and small size, Symjepi could be an attractive addition to this slice of the pharmaceutical world. In November 2017, the company also submitted a second new drug application to the FDA for a junior version (0.15 mg dose for children between 33 and 65 pounds).
Given the growing prevalence of life-threatening allergies, a new, lower-cost alternative should place the availability of this potentially life-saving drug within greater reach.