The US Food and Drug Administration approved the first nasal spray epinephrine drug for severe allergic reactions known as anaphylaxis, providing a needle-free alternative to EpiPens and similar medicines. <\/p>\n

The drug, called Neffy, is cleared for adults and children who weigh more than 66 pounds, the agency said Friday. It\u2019s given as a single dose sprayed into one nostril. A second dose may be given if needed, similar to injectable epinephrine, the agency said. <\/p>\n

Neffy uses the same spray device as Narcan, the naloxone nasal spray for opioid overdose, according to a spokesperson for its maker, ARS Pharmaceuticals. <\/p>\n

\u201cAnaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,\u201d said Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA\u2019s Center for Drug Evaluation and Research, said in a news release. \u201cThe availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.\u201d <\/p>\n

The approval was based on studies in 175 healthy adults measuring concentrations of epinephrine in the blood, which showed comparable levels for Neffy and injected epinephrine, as well as similar increases in blood pressure and heart rate. A study in children weighing more than 66 pounds found comparable epinephrine levels to those in adults. <\/p>\n

The drug had been expected to be approved last year, but that was delayed as the FDA sought more information about repeat dosing. The agency said Friday that patients may need to seek emergency medical assistance for close monitoring after experiencing anaphylaxis, and in case further treatment is needed. It\u2019s also recommended that patients who get injectable epinephrine seek immediate emergency care. <\/p>\n

The FDA noted that people who have nasal conditions like polyps or who have had nasal surgery may not absorb Neffy sufficiently and should talk with a health-care provider about whether an injectable epinephrine would be better for them. <\/p>\n

The most common side effects of Neffy include throat irritation, tingling nose, headache, nasal discomfort and feeling jittery, the FDA says. <\/p>\n

Anaphylaxis is most often caused by reactions to medication, foods or insect stings, according to the American Academy of Allergy, Asthma and Immunology. Symptoms, which typically start within five to 30 minutes of contact with an allergen, include hives, swelling of the throat and other areas, wheezing and passing out. <\/p>\n

\u201cAnyone who has experienced or witnessed an anaphylaxis reaction knows it can be very stressful deciding when to inject epinephrine to themselves or a child and often delay,\u201d Dr. Jonathan Spergel, chief of the allergy program at Children\u2019s Hospital of Philadelphia, said in a news release from ARS Pharmaceuticals. \u201cWe know that earlier administration is better, and for many, the needle is a barrier that causes dangerous hesitation. That is why the field has long pursued an effective treatment approach that does not require an injection.\u201d <\/p>\n

ARS Pharmaceuticals didn\u2019t disclose the list price of Neffy \u2013 how much it costs before insurance or other discounts \u2013 in its news release Friday. <\/p>\n

ARS Pharmaceuticals <\/strong>said that for people with commercial insurance that covers the drug, the price out of pocket would be no more than $25 for two single-use devices, via a co-pay program. For certain people who don\u2019t have insurance coverage or who face high out-of-pocket costs, the company said, the price would be $199 for two doses of Neffy. For other those who can\u2019t afford the medicine, the company said it would provide it for free. <\/p>\n

The medicine is expected to be available in the United States within eight weeks, ARS said. Lowenthal said it had manufactured several lots in anticipation of approval and is in the process of scaling up to be able to meet anticipated demand. <\/p>\n

He said the company\u2019s market research suggests that there are 3.2 million people \u201cthat really hate those autoinjectors, children that are terrified of needles,\u201d who are going to \u201cswitch very quickly\u201d to the nasal spray and that an additional 3.3 million people have had prescriptions written for injectable epinephrine but who haven\u2019t filled them and may switch, as well. <\/p>\n

ARS also believes that another 13.5 million people have been diagnosed with anaphylaxis who have never received a prescription, Lowenthal said, \u201cand now there\u2019s a safer, easier-to-use alternative \u2013 needle-free, pain-free \u2013 they\u2019ll be able to also protect themselves.\u201d <\/p>\n

Ultimately, Lowenthal expects an uptake of Neffy similar to nasal-spray naloxone, or Narcan, which he said accounts for 80% of use of the opioid-overdose reversal drug. He said his team has talked with companies that make emergency kits for airplanes, and the medicine could also be stocked in public places like restaurants. <\/p>\n

The FDA, Lowenthal noted, asked ARS to run studies of the drug using \u201cpasserbys,\u201d \u201csomebody we pull off the street who has no idea about this product, no idea about the disease.\u201d <\/p>\n

Those participants were put in a simulated experiment as if they were in a restaurant with another patron experiencing a severe allergic reaction, and they had to read the instructions and administer the drug, Lowenthal said. <\/p>\n