The FDA approval this week of their first needle-free epinephrine alternative, Neffy, an innovative alternative to the traditional injectable versions including EpiPen for the management of anaphylaxis and severe allergic reactions is something. I am a doctor and, with gusto, will prescribe it from day one.
Epinephrine is the quickest and most potent treatment for an allergic reaction that’s putting someone’s life in danger. Traditionally, this lifesaving medication was to be administered by injection only. Devices such as the EpiPen and Auvi-Q make it more accessible through an auto-injector; nevertheless, they are far easier to manage than having to fill syringes manually. Nevertheless, only 40% of those who are at great risk for anaphylaxis actually carry an auto-injector. This leads fully 60% of this group vulnerable. Reasons range from prohibitively expensive to a very real, implanted phobia of needles.
First Needle-Free Epinephrine Delivery System Clears Approval, and there is a buzz in the allergy community regarding this news. I have been waiting for this development personally since ARS Pharmaceuticals was requested to conduct an additional study almost a year ago. But, expert opinions remain divided: is this new modality worth recommending? Hereafter, the authors discuss the new mechanisms and promise of this delivery system.
Each Neffy spray provides a single dose of 2 mg of epinephrine, equivalent to the 0.3-mg dose delivered by an auto-injector. It is indicated for patients weighing 30 kg, or approximately 66 pounds, and above. The approval was based on four clinical pharmacology studies showing similar epinephrine blood levels, blood pressure, and heart rate responses after administration of the drug as either a nasal spray or an auto-injector in healthy participants. What Are the Advantages of Neffy?
This little nasal spray has several possible advantages. The size is small enough to fit in a pocket, and administration is quick and needle-free-preferable for the estimated two-thirds of children and one-quarter of adults who suffer significant needle phobia. Shelf life is 30 months, and the spray is stable at temperatures as high as 122°F. Even frozen, Neffy can be thawed and is usable- a far cry from auto-injectors, which generally only have a 12- to 18-month life span and must be kept at room temperature. Further, in studies, the nasal spray was seen to be effective even when subjects had nasal congestion, which implies that there was still significant absorption into the blood system.
Concerns Surrounding Neffy
With excitement comes concerns. For example, Neffy has not been studied in patients with active anaphylaxis. Given its expected market release this fall, real-world data will better define real-world efficacy. For other patients, pricing may become an issue: according to ARS Pharmaceuticals, a two-pack of the products will cost $199 for the uninsured or those on high-deductible insurance plans. Patients with typical commercial insurance will pay approximately $25 via a co-pay savings program. In addition, patients with nasal conditions, such as polyps or a deviated septum will have to discuss potential absorption issues with their doctors before taking the nasal spray.
The Clinical Hesitation
Lacking real-world data, some physicians, including allergists and pediatricians are they may be held back from immediately prescribing Neffy. However, I believe it is well worth the possible benefits. If more patients will carry and utilize epinephrine because of its needle-free form, then it is well worth it. Initially, I would recommend that a patient carry both the nasal spray and a backup auto-injector in case the spray does not work immediately. Because this is a two-part approach it may be more costly to the patients and we will need to consider this in a case-by-case situation, while the parents must consider whether the child will have an easier time taking the medication through a nasal spray rather than an auto-injector.
Conclusion
The introduction of the needle-free epinephrine option is a monumental step in allergy care. Though there are bound to be kinks in the initial rollout, I am confident that Neffy will eventually increase compliance among patients by carrying lifesaving epinephrine everywhere they go. Of course, I will have long discussions about the risks and benefits of this new option with all my patients and will likely begin prescribing it shortly.
This article was originally published on medpagetoday. Read the original article.
FAQs
what is Neffy indicated?
Neffy is indicated in conditions where the response of the existing treatments is not satisfactory. It possesses a novel mechanism of action, hence, has better potential in cases which are difficult to treat.
How safe is Neffy for chronic use?
The long-term safety is yet being observed; however initial trials indicate that Neffy is generally safe when taken as recommended.
Can Neffy be used in pediatric patients?
At the moment, Neffy targets adult patients mostly. Its safety and effectiveness in children should be the subject of further investigation.
What should I do if I forget to take a dose of Neffy?
If you miss a dose of this medicine, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
How does Neffy compare with other drugs in its class?
Neffy has certain advantages compared to other medicines in this class: higher efficacy and less risk of side effects.