Patients with food, drug and stinging insect allergies should be able to get their prescriptions filled for the neffy epinephrine sprayer in the coming days.
ARS Pharmaceuticals announced on Sept. 23 that neffy, the first non-needle treatment for severe allergic reactions, is now available from U.S. pharmacies. Neffy sprayers are also being shipped from an online pharmacy to patients who pre-ordered on neffy.com.
“Pharmacies are processing prescriptions, our supply chain is fully operational, and most importantly, the first patients are now receiving neffy,” says ARS Pharma’s Chief Commercial Officer Eric Karas.
The Food and Drug Administration approved neffy on August 9 for adults and children weighing 66 pounds and up. Since the approval, ARS Pharma’s President and CEO Richard Lowenthal says “the level of excitement has been very high.”
With the FDA’s green light, the company moved quickly to ramp up manufacturing and start shipping to pharmacy distributors.
“We’ve had a lot of people contacting us saying, ‘I have a prescription and I’m trying to find a pharmacy that’s carrying it,’” Lowenthal tells Allergic Living. “The team at ARS is thrilled that we are able to make it available, a little quicker than we anticipated.”
How to Get Neffy Sprayers
Patients have a couple of options for ordering neffy epinephrine sprayers, which come in a pack of two. You can go see your allergist, request a neffy prescription and have it filled through your regular retail pharmacy.
Although pharmacies are unlikely to have stock of neffy just yet, pharmacists can order the medication from distributors and have it within a couple of days, says Lowenthal.
A second option for patients is to go to neffy.com. There, you can upload your prescription for neffy sprayers and receive the medication in the mail from an online pharmacy, BlinkRx. Patients who need a prescription can also schedule an online appointment with a telehealth provider for $35 on neffy.com.
Lowenthal estimates that about 20 percent of insurance plans currently cover neffy epinephrine sprayers. Most plans, however, don’t yet include neffy on prescription formularies, so prior authorization is needed for insurance coverage.
Physicians can request prior authorization. Or, ARS Pharma will facilitate this for patients who order the medication through neffy.com.
Neffy Pricing, Insurance
Patients with insurance coverage for neffy may pay as little as $25 for a two-pack of neffy sprayers by using this coupon.
For people without insurance or whose insurance will not cover neffy, the cash price for a two-pack is $199. People below certain income thresholds may also qualify to receive neffy at no charge through a patient assistance program.
Lowenthal says it will take six months to get neffy on the majority of prescription drug plan formularies, but insurers are interested.
“A number of insurance companies have been reaching out to us, which is unusual,” Lowenthal says. He believes insurer interest has been piqued by publicity surrounding the approval and the allergy community’s interest in the medication.
Neffy’s shelf life, or expiration date, is 30 months. By comparison, epinephrine auto-injectors expire after 12 to 18 months.
Studies Behind Neffy Sprayers
Neffy’s approval was based on four studies in 175 healthy adults not experiencing anaphylaxis. The studies compared concentrations of epinephrine in the blood after using the neffy sprayer and after administering an epinephrine auto-injector or a manual syringe.
The results of these studies showed comparable epinephrine blood concentrations between neffy and epinephrine injection products. The FDA says neffy also showed similar increases in blood pressure and heart rate as the epinephrine injection devices.
Lowenthal credits the dedication of the allergy community and healthcare providers for paving the way for neffy as the first needle-free epinephrine treatment for severe allergies. “Now that people can begin using neffy, we are looking forward to seeing how it positively impacts up to 40 million people in the U.S. who experience severe allergic reactions.”
Neffy for Smaller Kids, Europe Update
ARS Pharmaceuticals has also now submitted a supplemental new drug application to the FDA for a 1 mg neffy sprayer for smaller children weighing 33 to 66 pounds. The FDA has until early March 2025 to issue its decision on the lower dose for kids.
If approved, Lowenthal expects the 1 mg dose for smaller kids will be available by summer 2025, in time for the next school year.
ARS Pharmaceuticals is also working on a partnership agreement with a pharmaceutical company in Europe to make neffy available there.
In late August, the European Commission approved EURneffy for the emergency treatment of allergic reactions in the European Union. The company expects EURneffy to be available in some European Union countries by the end of 2024. Germany will likely be first.
The United Kingdom, although not part of the EU, will likely follow, Lowenthal says. ARS Pharma is planning on filing for approval with regulators there in December 2024. A streamlined process should deliver an approval decision in the U.K. by March 2025, he says.
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