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CEO Expects Approval and Launch of Intranasal Emergency Epinephrine Spray by Summer 2023

When anyone has an attack of anaphylaxis, we know that epinephrine is a life-saving treatment. We also know that for a lot of people, “fear of the jab” is one of the things that prevents them from using epinephrine; the medication must be administered by intermuscular injection. By the Summer of 2023, according to the CEO of ARS Pharma Richard Lowenthal, a new method to administer epinephrine may help make that fear obsolete.

CEO Expects Approval and Launch of Intranasal Emergency Epinephrine Spray by Summer 2023

ARS-Pharma Research promo pix

By Dave Bloom
2022/03/02

SnackSafely.com has been following the progress of a number of emergency epinephrine auto-injector alternatives over the years. These provide an alternate means of delivering epinephrine in an anaphylactic emergency to the needle used in traditional auto-injectors like EpiPen and prefilled syringes like Symjepi.

Why is this important? Because a delay in administering epinephrine during anaphylaxis results in poorer outcomes, and “fear of the jab” can sometimes lead people to delay administering the drug. The bulkiness of some brands of auto-injectors can also result in people leaving them at home when they should be carrying two doses with them at all times. 

“Having a non-needle delivery device would help many people overcome that fear and hopefully increase use in anaphylaxis,” said David Stukus, MD, an allergist-immunologist and professor of clinical pediatrics at Nationwide Children’s Hospital, Columbus, Ohio who was not involved with any of the studies of epinephrine alternatives. And “it’s not just food allergy — anaphylaxis can occur from venom stings, medications, or idiopathic causes.”

Yesterday, we reported on the progress of Aquestive’s AQST-109, a thin film smaller than a postage stamp that is placed under the tongue to administer epinephrine.

We’ve also covered two intranasal epinephrine devices: Bryn Pharma’s BRYN-NDS1C and ARS Pharmaceuticals’ Neffy™. Both deliver epinephrine via specially designed nasal spray devices, work fine even if the user is suffering from nasal congestion, and don’t require the user to inhale.

 We often field questions about when these alternatives might finally come to market and our answer is generally “sometime in the next few years”. Clinical trials can often lead to unexpected results, forcing pharma companies to reformulate or redesign their products, leading to delays in acquiring the necessary FDA approval. (For an example, see how the peanut allergy therapy Viaskin Peanut has fared.)

But an interview with ARS Pharma CEO Richard Lowenthal in Medscape Medical News is finally lifting the curtain on the expected date for the launch of Neffy. Lowenthal told Medscape that ARS Pharmaceuticals is hoping for approval and launch of its nasal spray by summer 2023.

So with fingers crossed, the market for epinephrine delivery may expand to include non-needle alternatives next year. And new entrants to the emergency epinephrine market will increase supply and lower prices due to increased competition. 

Again, keep your fingers crossed!

Source: Needle-Free Epinephrine Products Could Be Available in 2023 — Medscape Medical News