First nasal spray epinephrine drug for emergency allergic reactions gets FDA approval

(CNN) The US Food and Drug Administration has approved the first epinephrine nasal spray to treat a severe allergic reaction called anaphylaxis, providing a needle-free alternative to EpiPens and similar medications.

The drug, called Nephi, is approved for use in adults and children weighing 66 pounds or more, the agency said Friday. The drug is administered as a single spray into one nostril. Like injectable epinephrine, it can also be given a second dose if needed, the agency said.

Nephi uses the same spray device as Narcan, a naloxone nasal spray for opioid overdoses, according to a spokesman for manufacturer ARS Pharmaceuticals.

“Anaphylaxis can be life-threatening, and people, especially children, may delay or avoid treatment because of their fear of injections,” Dr. Kelly Stone, associate director of the division of pulmonary, allergy and critical care in the FDA’s Center for Drug Evaluation and Research, said in a news release. “The availability of an epinephrine nasal spray may reduce a barrier to prompt treatment of anaphylaxis.”

The approval was based on a study of 175 healthy adults that measured epinephrine levels in the blood and found that Nefi and injected epinephrine had similar levels and increased blood pressure and heart rate. A study of children weighing 66 pounds or more found that their epinephrine levels were similar to those in adults.

The drug was expected to be approved last year, but its approval was delayed as the FDA sought more information on repeated dosing. The FDA said on Friday that after experiencing anaphylaxis, patients may need to seek emergency medical help for close monitoring and in case further treatment is needed. It also advises that patients who have received injectable epinephrine seek emergency medical care immediately.

The FDA noted that people with nasal diseases such as polyps or who have had nasal surgery may not absorb Nephi well and should talk to their health care professional about whether injectable epinephrine might be a better option.

According to the FDA, the most common side effects of Nefi include throat irritation, nasal tingling, headache, nasal discomfort, and nervousness.

According to the American College of Allergy, Asthma and Immunology, anaphylaxis is most often caused by a reaction to a medicine, food, or insect sting. Symptoms usually begin within 5 to 30 minutes of contact with the allergen and include hives, swelling in the throat or throat, wheezing, and fainting.

“Anyone who has experienced or witnessed an anaphylactic reaction knows that deciding when to give yourself or your child an epinephrine injection can be extremely stressful and often leads to postponement,” Jonathan Spergel, MD, director of the Allergy Program at Children’s Hospital of Philadelphia, said in an ARS Pharmaceuticals news release. “We know the sooner it’s administered the better, and for many people, needles are a barrier that creates dangerous hesitation, which is why the field has long sought effective treatments that don’t require injections.”

ARS Pharmaceuticals said in a conference call with investors that the list price for a pack of two Nephi will be $710. But ARS said copays will be lower than brand-name and generic injectors, and Nephi has a longer shelf life of 30 months compared with about 18 months for auto-injectors.

ARS Pharmaceuticals said that for people with private insurance that covers the drug, out-of-pocket costs will be less than $25 for two disposable devices through a copayment program. For those without insurance or with high out-of-pocket costs, the cost will be $199 for two doses of Nephi, the company said. For those who cannot afford the drug, the company said it will provide it free of charge.

ARS said the drug should be available in the U.S. within eight weeks. The company has made several batches in anticipation of approval and is scaling up production to meet expected demand, said Chief Executive Richard Lowenthal.

He said the company’s market research indicates there are 3.2 million “kids who hate auto-injectors and are afraid of needles” who will switch to the nasal spray “soon,” and that a further 3.3 million have received prescriptions for injectable epinephrine but have not yet filled them and are looking to switch as well.

ARS also believes there are another 13.5 million people who have been diagnosed with anaphylaxis but never received a prescription, Lowenthal said, “and now there’s a safer, easier-to-use alternative — needle-free, painless — that will allow them to protect themselves, too.”

Lowenthal hopes that Nephi will eventually be as widely available as nasal naloxone (Narcan), a drug that reverses opioid overdoses. He says 80% of the drug’s uses are from nasal naloxone. His team is in talks with a company that makes emergency kits for airplanes, so that public places like restaurants could potentially stock Nephi.

Lowenthal noted that the FDA had asked ARS to conduct research on the drug among “passersby” — “people on the street who know nothing about the product or the disease.”

Participants were given a simulated test in which they were in a restaurant where another customer was having a severe allergic reaction, and they had to read the instructions and administer the medication, Lowenthal said.

“They did it 100 percent right, without any instruction or training,” he said.

The company also plans to apply for FDA approval of Nephi for children weighing 15 to 30 kilograms (33 to 66 pounds) by the end of the third quarter of this year, in October. Lowenthal said this will be a lower dose, just as EpiPen is sold in a lower dose for smaller children.

“Allergy experts have been waiting for this and are pleased that the FDA has approved it,” said Dr. Purvi Parikh, a New York immunologist and allergist who is not affiliated with ARS Pharmaceuticals.

“This is very important because many patients, including children and their caregivers, have a fear of needles and therefore do not use an EpiPen in a crisis situation,” she said.

“Like Narcan, this will save lives,” she added.