Neffy is a new epinephrine intranasal spray being developed to treat severe allergic reactions such as anaphylaxis. Currently epinephrine is given in an injectable form under the names Epipen, Auvi-Q and others.
Recently and advisory council to the FDA recommended the approval of Neffy which has the same active ingredient as injectable epinephrine to be used for severe allergic reactions. If approved, it would be approved for adults above 66 pounds. Currently in the injectable form, the epinephrine dose is 0.3 milligrams, but the intranasal form would be dosed at 2 milligrams.
The trials performed by the drug manufacturer, ARS Pharma showed the results for Neffy “were neither substantially higher or lower than injectable epinephrine.” To measure the effects of Neffy, the trials showed that effects of blood pressure and heart rate were comparable to Epipen.
The FDA will likely make their decision in the middle of this year.
Advantages of this product is that there can be some hesitancy in patients to use an injectable epinephrine and an intranasal form could be more accepted. Also the device is a smaller than the injectable epinephrine products, which would make it easier to carry around and more widely accepted.
Some committee members are still hesitant to approve it because its hard to compare it to injectable epinephrine, as it has been being used since 1901.
There have many issues with the price of injectable epinephrine over the years, most notably with Epipen. There have been several generic versions that have come to the market that have made it more affordable.
There is no price for Neffy yet, but like all new medications that come to the market, the price usually is very high and usually manufacturers have coupons that bring down the price.
If and when Neffy is approved, it will be approved for adults, but the company is also working on a pediatric indication as well.
UPDATE SEPTEMBER 19, 2023
In a stunning announcement the FDA did not approve Neffy, they told ARS Pharmaceuticals that it needed to conduct another study before they could approve it. The FDA is going against the agency’s advisory committee which had recommended it in May. The FDA was most likely concerned by the lack of clinical data as it was not studied in people experiencing anaphylaxis. This kind of study would be hard to do for obvious reasons that you would not want a person to undergo anaphylaxis and potentially die during a study. And most studies need a placebo control, so if you do have a person who does undergo anaphylaxis for the study, giving them a placebo could potentially kill them as well.
The company plans to appeal the decision. The company said Neffy was comparable to the Epipen based on animal studies, as well as in people without anaphylaxis.
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