New Treatment for Anaphylaxis
Anaphylaxis is an acute, severe, and life-threatening allergic reaction. The most common triggers for anaphylaxis include allergenic foods, medications, and insect stings. Symptoms usually begin within a few minutes of exposure of the triggering agents. Initially, the symptoms characteristically involve the skin which typically causes itching and hives followed by swelling of the soft tissues. Unless treated, the reaction may rapidly progress and may involve other organ systems (e.g., respiratory, gastrointestinal, cardiovascular) resulting in symptoms such as shortness of breath, wheezing, coughing, nausea, vomiting, abdominal pain, dizziness, drop in blood pressure, and/or loss of consciousness.
The only effective treatment for anaphylaxis is epinephrine. If given early in the process, it can stop the reaction from progressing and can be life-saving. As anaphylactic reactions can occur after accidental exposures anywhere and at any time, it is recommended to have epinephrine readily available at all times for those at risk for anaphylaxis.
Until now, the only form of epinephrine available was an injectable form. The epinephrine is injected into a muscle either with a syringe and a needle or with an autoinjector device. There are a few autoinjectors available in different shapes and sizes and dome of the brand names include EpiPen, Auvi-Q, and Adrenaclick. Autoinjectors are preloaded with different doses of epinephrine suitable for adults and children. One problem with autoinjectors is that some patients and parents of children at risk for anaphylaxis are not comfortable in using them because they are squeamish about needles. As a result, a hesitancy in the use of epinephrine can lead to a delay in administering the needed treatment in a life-threatening situation which can be detrimental.
On August 9, 2024, the Food and Drug Administration FDA) approved a new form of epinephrine that is delivered into the nostrils by way of a nasal spray device. It is called Neffy and it uses the same delivery device used to administer other medications into the nasal cavity such as Narcan, a drug useful in reversing the effects of opiates.
Neffy delivers 2 mg. of epinephrine into the nasal cavity. (Epipen is available in 0.3mg. and 0.15mg. dosage strengths). In clinical trials, Neffy resulted in comparable blood levels of epinephrine to injectable forms, with a shorter onset of action. It also showed that it can increase the blood pressure and heart rate rapidly, which are indicators for the reversal of the reaction.
This nasal epinephrine formulation is approved for adults and children weighing 30 kg. (66 lbs.) and above. Neffy is a single dose nasal spray administered into one nostril. It is available as a 2-pack, which is similar to injectable forms. It is recommended to administer the second dose on Neffy from a different device into the same nostril if the anaphylactic symptoms persist 5 minutes after the initial dose.
It is hoped that the nasal spray would remove some barriers for early usage of epinephrine (i.e. the fear of injections) and thus would meet an unmet need. The manufacturer says that most commercially insured patients will pay approximately $25 as copay for a 2-pack, while also offering assistance for patients who are not insured. The medication has a shelf-life of about 30 months and is stable at wide temperature ranges.
Neffy was also studied in patients with nasal congestion due to allergies and infections and it was shown to be well absorbed from the nasal cavity without losing its efficacy. Note however that Neffy was not studied in patients with nasal polyps and in patients after nasal surgeries, so its efficacy in these patients is currently unknown.
The side effects observed in clinical trial participants included throat irritation, tingling sensation in the nose, runny nose, nasal congestion, headaches, jitteriness, and dizziness. Neffy should also be used with caution in patients with a history of allergic sensitivity to sulfites.
Neffy is expected to be available in the pharmacies in October 2024.
The board certified allergists at Black & Kletz Allergy see both adult and pediatric patients and have over 5 decades of experience in the field of allergy, asthma, and immunology. Black & Kletz Allergy has 3 convenient locations with on-site parking located in Washington, DC, McLean, VA (Tysons Corner, VA), and Manassas, VA. The Washington, DC and McLean, VA offices are Metro accessible and we offer a free shuttle that runs between the McLean, VA office and the Spring Hill metro station on the silver line. To schedule an appointment, please call any of our offices or you may click Request an Appointment and we will respond within 24 hours by the next business day. We look forward to providing you with the newest cutting edge allergy care in a welcoming and relaxed environment.