Allergic reactions can sometimes be life-threatening. Anaphylaxis is a severe allergic reaction that is characterized by a sudden onset of symptoms with rapid progression. The manifestations may include generalized itching (i.e., pruritus), hives (i.e., urticaria), swelling (i.e., angioedema) of soft body parts, rapid pulse rate, a precipitous drop in blood pressure, dizziness, nausea, vomiting, abdominal pain, wheezing, shortness of breath, and/or loss of consciousness. Anaphylactic reactions are usually triggered by allergies to foods (e.g., peanuts, tree nuts, fish, shellfish), insect venoms (e.g., bee, wasp, yellow jacket, hornet, fire ant), and/or medications.
Administration of epinephrine immediately after the onset of an anaphylactic reaction usually stops the reaction from progressing and can be lifesaving. Occasionally, more than one dose of epinephrine is needed to reverse the untoward effects of anaphylaxis. Until now, the only approved route of the administration of epinephrine into the body has been through an injection with a syringe and needle. Epinephrine auto-injector devices such as EpiPen, Auvi-Q, and Adrenaclick have been available for several years. These self-injectable epinephrine devices are easy to use and allows the patient to administer epinephrine as soon as early anaphylactic allergic symptoms develop.
On May 11, 2023, an expert panel of advisers recommended to the Food and Drug Administration’s (FDA) that they approve an epinephrine nasal spray product, clearing a key hurdle for what could soon be the first needle-free option for treating severe allergic reactions.
The device which is designed to deposit epinephrine into the nostril is called Neffy. The same device was previously approved to administer a medication called naloxone into the nose to reverse the effects of a narcotic overdose.
Neffy delivers 2 mg. of epinephrine which is suitable for patients weighing above 30 kilograms (66 lbs.). The FDA is likely to decide on the final approval process in the next few months. If approved, the device will be available for use before the end of the 2023 year.
During clinical trials, the epinephrine nasal spray administration was compared with the previously approved injectable epinephrine products (i.e., EpiPen, Auvi-Q, Adrenaclick) in more than 600 individuals. The nasal spray has demonstrated comparable efficacy and rapidity of action, in most cases within a minute of administration. The effects on blood pressure and pulse rate, which were surrogate markers for the reversal of reaction, were non-inferior to injectable epinephrine. When a second dose is needed, the nasal spray showed a slightly better response than with injections. The epinephrine concentrations in the bloodstream also did not differ substantially with either route of administration.
Neffy’s safety profile was comparable with an injection of epinephrine with mild reactions that did not include any meaningful nasal irritation or pain. Intranasal delivery and pharmaco-dynamic response also were effective even with nasal congestion or a runny nose, such as when patients are experiencing allergic rhinitis (i.e. hay fever) or an upper respiratory tract infection (URI).
During clinical studies, the researchers also found that patients are more likely to use the nasal spray much earlier than the injection, which is advantageous in reversing the anaphylactic reaction. The other benefits of the nasal spray are that the nasal spray is more convenient to carry and there obviously was no needle- related injuries since no needle is needed.
If approved by FDA, the intranasal epinephrine could offer a preferred alternative to injectable epinephrine devices and meet an unmet need. Many individuals fail to use self-injectable epinephrine devices when anaphylaxis arises. Some find the pen-style devices inconvenient to carry. Some are reluctant to use them because they are fearful of needles, while others panic when an anaphylactic reaction occurs. Having an epinephrine nasal spray available is a welcome addition to the arsenal of medications used to combat and treat severe allergic reactions.
The board certified allergy specialists at Black & Kletz Allergy has 3 locations in the Washington, Northern Virginia, and Maryland metropolitan area. We have offices in Washington, DC, McLean, VA (Tysons Corner, VA), and Manassas, VA. All 3 of our offices have on-site parking and the Washington, DC and McLean, VA offices are Metro accessible. The McLean office has a complementary shuttle that runs between our office and the Spring Hill metro station on the silver line. The allergists of Black & Kletz Allergy diagnose and treat both adult and pediatric patients. For an appointment, please call our office or alternatively, you can click Request an Appointment and we will respond within 24 hours by the next business day. The allergy doctors at Black & Kletz Allergy have been helping patients with anaphylaxis, hives, insect sting allergies, food allergies, medication allergies, hay fever, asthma, sinus disease, eczema, and immunological disorders for more than 5 decades. If you suffer from allergies, it is our mission to improve your quality of life by reducing or preventing your undesirable and irritating allergy symptoms.