The FDA recently approved the first needle-free epinephrine product (neffy), an alternative to injectable epinephrine (EpiPen) for anaphylaxis and other allergic reactions, but caution will be needed when it comes to treatment, writes Dr Zachary Rubin in Medpage Today.
He writes:
If someone experiences a severe allergic reaction – anaphylaxis – epinephrine is the fastest, most effective treatment. But the only route through which people could receive this life-saving medication, until recently, was via injection.
Epinephrine is available in an auto-injector such as EpiPen and Auvi-Q, so it’s easier and faster to administer than drawing up epinephrine in a syringe.
However, only 40% of the highest-risk people who need to carry an auto-injector actually do – leaving 60% at risk. This may be for various reasons, including the high costs of the devices and fear of needles.
Now, with the approval of the new epinephrine nasal spray, the first needle-free alternative to epinephrine auto-injectors, the allergy world is abuzz with excitement.
I have been anxiously waiting for the FDA to approve the nasal spray since they asked ARS Pharmaceuticals for an additional study nearly a year ago.
But expert opinions are mixed. Is it worth prescribing?
The nasal spray contains 2mg of epinephrine per dose, which is equivalent to a 0.3mg dose found in an auto-injector, and is approved for people who weigh at least 30kg. The approval was based on four clinical pharmacology studies showing that epinephrine blood concentrations, as well as blood pressure and heart rate, in healthy individuals, was similar whether they received epinephrine through the nasal spray or an auto-injector.
There are several potential advantages to using the spray. It is small, can fit into a pocket, and can be quickly administered without the fear of using a needle (as many as two in three children and one in four adults have significant fears of needles). It has a shelf life of 30 months and can withstand temperatures up to 50 degrees C.
If the epinephrine nasal spray becomes frozen, it can still be thawed and used. On the other hand, epinephrine auto-injectors only last for 12-18 months and need to be stored at room temperature.
The epinephrine nasal spray has been tested in people who have a stuffy nose and it appears it still absorbs well into the bloodstream.
There are, however, some potential concerns. The spray was not studied in people who were experiencing anaphylaxis. When the nasal spray is rolled out this month, I expect real world studies will be conducted to determine its true effectiveness.
Additionally, cost may be a concern for some – according to ARS Pharmaceuticals, a two-pack will cost $199 for uninsured patients – and also, people will need to discuss with their doctor whether they can use the spray if they have a history of nasal polyps, deviated septum, and/or nasal surgery, because these conditions may have an impact on absorption.
Because real-world data are not available yet, some allergists, paediatricians, primary care doctors, and other physicians may be hesitant to prescribe the spray right away.
However, I believe the benefits outweigh the risks: if it means more patients will carry the drug with them and are more likely to use it, then it’s worthwhile. The safest approach when starting is to encourage patients to hold on to both the spray and an epinephrine auto-injector.
If the nasal spray does not work quickly, then your patients will have an injectable device as a backup. However, this may be costly for patients, so please take that into consideration when working with individual patients or families.
Parents will also need to assess whether their children will tolerate a nasal spray versus an auto-injector.
I am excited that there is now a needle-free option for epinephrine. I believe that over time, it will encourage more people to carry this lifesaving drug with them at all times.
Although there are some potential challenges during the initial rollout, I will be counselling my patients about the risks and benefits of using the epinephrine nasal spray, and l will be prescribing this medication as soon as it becomes available in the coming weeks.
• Rubin is a US paediatrician specialising in allergy and immunology.
Medpage Today article – Neffy Is About to Hit Shelves: Considerations for Prescribing (Open access)
See more from MedicalBrief archives:
EU approves first nasal spray for allergy reaction
FDA fast tracks Epinephrine nasal spray for anaphylaxis
Needle-free anaphylaxis drug thwarted by FDA