Advocates ‘very excited’ by FDA approval of epinephrine nasal spray
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Key takeaways:
- Neffy nasal spray is the first FDA approved needle-free epinephrine alternative.
- The spray is as effective as autoinjectors.
- Patients who are afraid of needles may be more inclined to carry the spray.
Advocates were pleased to learn about the FDA’s approval of ARS Pharmaceuticals’ neffy epinephrine nasal spray, which may have a significant impact on the safety and quality of life of families with allergy.
The spray was approved earlier this month for the treatment of type 1 allergic reactions such as anaphylaxis in adults and children who weigh 30 kg (66 lb) or more. It was designed as an alternative to manual injections and autoinjectors with epinephrine.
“We are very excited for FDA’s approval of neffy epinephrine nasal spray,” Lynda Mitchell, MA, CAE, CEO of Allergy & Asthma Network, told Healio.
For the first time, Mitchell continued, this approval means that patients at risk for anaphylaxis will have a needle-free alternative.
“The response from the food allergy community especially has been extremely positive,” she said. “As a food allergy mom myself, I understand their excitement for this new nasal spray option for anaphylaxis.”
Though effective, autoinjectors have limitations, Thomas B. Casale, MD, professor of medicine and pediatrics and chief of clinical and translational research at the USF Health Morsania College of Medicine’s division of allergy and immunology, told Healio.
“The biggest one is that many patients and caregivers are afraid of needles. As a result, some patients either do not use or delay using epinephrine autoinjectors,” Casale said. “In addition, they are somewhat bigger and bulkier, which can make them harder to carry.”
Autoinjectors are more susceptible to heat and sunlight and have a relatively short shelf life as well, he added.
“Finally, there is a risk of intravascular injection instead of intramuscular, and caregivers administering epinephrine can make a mistake and inadvertently inject themselves,” Casale said.
As an easy to use and more compact option with a longer shelf life and fewer issues with heat and sunlight, neffy’s advantages are clear, he said.
“However, the biggest advantage is that one does not have to be concerned about needles and the complications listed above,” Casale said.
Mitchell said these advantages will lead people who hesitate to keep their autoinjectors with them to carry neffy with them instead.
“We want more people to carry epinephrine and use it when they need it. We want people to not hesitate to use epinephrine and use it as their first line of treatment when signs of anaphylaxis occur,” she said.
Mitchell also noted the Allergy & Asthma Network’s motto of “epi first, epi fast” for emergency situations.
“We are hoping that people who may hesitate to inject themselves or their child will not hesitate to use a nasal spray epinephrine,” she said. “A nasal spray option will also be easier for caregivers to use. Think of school personnel, school coaches, camp counselors and others who may have to assist with administering epinephrine.”
Families with allergy do not have to be concerned about neffy’s effectiveness compared with autoinjectors, Casale said.
“Neffy performed up to the FDA recommendations of having a bracketed [pharmacokinetic] and [pharmacodynamic] profile in comparison to an epinephrine autoinjector and intramuscular needle and syringe administration,” Casale said.
These results came from studies that examined single and double doses, with epinephrine blood levels, associated increases in blood pressure and heart rate, and safety and tolerability signals that equaled or surpassed comparable treatments as well.
“There were no significant safety concerns beyond what was expected for epinephrine administration, increased BP and HR,” Casale said. “Also, without a needle, many of the concerns about intravascular or inappropriate administration were obviated.”
The FDA had asked ARS Pharmaceuticals to specifically test neffy’s efficacy in patients with nasal congestion. Casale said that these concerns were addressed.
“Patients who had upper respiratory viral infections or an induced allergic rhinitis challenge responded very well to neffy administration with good PK/PD results for both single and two doses,” he said.
“Moreover, since this is the same device used for many other medications, including Narcan (naloxone hydrochloride, Emergent BioSolutions), one would expect that administration under many adverse conditions would be effective and safe,” he continued.
Mitchell said neffy’s arrival is an option for patients at risk for anaphylaxis.
“People now have a choice. If they want to stay with the autoinjectors they have relied on for many years, they can do so. If not, they discuss with their doctor about neffy nasal spray epinephrine,” she said.
“We are advocates for patient-centered care and making sure that treatments reflect people’s preferences and values. A nasal spray epinephrine treatment allows people to have a preference for a different way to treat anaphylaxis if that is what they want.”
Allergy & Asthma Network has been “getting the word out” about neffy’s FDA approval, and the response from the allergy community has been extremely positive, Mitchell said.
“Health care professionals are also excited to have a new treatment option to offer patients and families,” she added.
Allergy & Asthma Network will update the educational information on its English and Spanish websites to include information about neffy. The organization also plans on sharing that information via its webinars, videos, podcasts and other communication channels.
“Also, we will be sharing information as we know it regarding access to this new treatment, discount programs, and advocating for health plans and other insurers to include neffy on their approved list of drugs (formularies) at a cost that patients and families can afford,” Mitchell said.
“I’ve been part of the allergy community for almost 35 years, when my baby at the time developed multiple food allergies. I’ve had to use epinephrine autoinjectors over the years and have been very grateful to have the peace of mind in having them available to use if I needed them,” she said.
“I’m also very excited about the recent research and innovation that has been life-changing for so many living with food allergies,” she added.
Next, Mitchell said she is looking forward to FDA approval of neffy for younger children who weigh less than 66 lb.
“Many parents and caregivers would be so grateful to be able to use a nasal spray rather than a needle-based epinephrine autoinjector for their young children,” she said. “It should be no surprise that children do not like needles and parents do not like to have to inject their children.”
Allergy & Asthma Network also supports additional new treatment options that would give patients and families even more choice, Mitchell continued.
“We know that additional needle-free epinephrine treatments are in clinical trials that, if approved, will give people additional options to choose from,” she said.
But despite this progress, including ongoing research that has yielded a better understanding of how to prevent food allergy and allergic reactions, there is still no cure for food allergy and anaphylaxis still needs to be treated when it happens, Mitchell said.
“With that in mind, we have a continuing need for more patient and family education to understand food allergy management, especially when newly diagnosed,” she said.
There also is a need to ensure that patients and families with allergy know how to stay safe day-to-day and not hesitate to treat anaphylaxis when it happens, in addition to needs for more care.
“We need more patients and families to have access to board certified allergists so they can get properly diagnosed and get an action plan and treatment plan in place,” she said.
This access needs to expand to underserved populations as well, she said.
“We’ve seen so much innovation and progress, especially in recent years,” Mitchell said.
“But there are still many people with food allergies, especially in Black, Hispanic and Asian communities, who have a higher prevalence of food allergy, yet often don’t have access to doctors and specialists to get the food allergy diagnosis and treatment they need,” she said. “It is a big challenge, but a critical area where we need to work together to find solutions.”
For more information:
Thomas B. Casale, MD, can be reached at tbcasale@usf.edu. Lynda Mitchell, MA, CAE, can be reached at lmitchell@allergyasthmanetwork.org.