US approves nasal spray alternative to injection-based EpiPen for severe allergic reactions
The United States Food and Drug Administration (FDA) on Aug. 9 approved a nasal spray that's meant to treat severe allergic reactions, serving as an alternative to needle-based remedies like EpiPen.
On its website, the FDA said it approved ARS Pharmaceuticals' Neffy for the emergency treatment of allergic reactions, including those that are life-threatening, in adult and pediatric patients who weigh at least 30 kg. (about 66 lbs.).
"Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, associate director of the FDA Center for Drug Evaluation's Pulmonology, Allergy and Critical Care Division. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.”
According to World Allergy Organization, during an anaphylactic shock or anaphylaxis, the immune system releases a flood of chemicals, in which blood pressure drops suddenly and the airways narrow. Signs and symptoms include a rapid, weak pulse, a skin rash, as well as nausea and vomiting.
It can occur within seconds or minutes of exposure to an allergen.
The FDA said Neffy is a single-dose nasal spray administered into one nostril. Like epinephrine injection products, a second dose (using a new nasal spray to administer Neffy in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen.
After using Neffy, like EpiPen, the FDA said patients may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.
Neffy's most common side effects include throat irritation, tingling nose, headache, nasal discomfort, feeling jittery, tingling sensation, fatigue, tremor, runny nose, itchiness inside the nose, sneezing, abdominal pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea, and vomiting.
According to CBS News, the FDA didn't approve of Neffy almost a year ago, saying that at the time, more data was needed to evaluate its safety on repeated doses.
ARS Pharmaceuticals said people with commercial insurance that covers the drug may purchase Neffy for $25 (P1,400) for two single-use devices via a co-pay program.
Otherwise, it costs $199 (P11,300) for two doses.
The company said it would provide free Neffy for those who can’t afford the medicine.
It's expected to become available in the United States within eight weeks, ARS Pharmaceuticals said.