The US Food and Drug Administration (FDA) has granted approval for the first-ever nasal spray epinephrine drug, providing a convenient, needle-free option for treating severe allergic reactions, also known as anaphylaxis. The drug, called Neffy, has been cleared for use in adults and children weighing over 66 pounds.

Administered as a single dose sprayed into one nostril, Neffy offers an alternative to injectable epinephrine, such as EpiPens, and works similarly by increasing blood pressure and heart rate. Neffy employs the same spray device as Narcan, the nasal spray used for opioid overdose reversal.

Anaphylaxis is a potentially life-threatening condition often caused by reactions to medications, foods, or insect stings. Symptoms, which can manifest within minutes of exposure to an allergen, include hives, throat swelling, wheezing, and fainting. The fear of injections, especially among children, may sometimes result in delayed or avoided treatment, making the availability of epinephrine nasal spray an important breakthrough.

The FDA's approval of Neffy was based on studies involving 175 healthy adults, demonstrating comparable levels of epinephrine in the blood for Neffy and injected epinephrine, along with similar increases in blood pressure and heart rate. Additionally, a study involving children weighing over 66 pounds found comparable epinephrine levels to those observed in adults.

ARS Pharmaceuticals, the company behind Neffy, has yet to disclose the drug's list price, but CEO Richard Lowenthal revealed that Neffy's shelf life is longer than injectable epinephrine, lasting for 30 months compared to 18 months for autoinjectors like Auvi-Q. The company plans to make Neffy available within the United States in approximately eight weeks.

Recognizing that some individuals may not adequately absorb Neffy, particularly those with nasal conditions or prior nasal surgery, the FDA advises consulting with a healthcare provider to determine whether injectable epinephrine would be a better option. The most common side effects of Neffy include throat irritation, tingling nose, headache, nasal discomfort, and restlessness.

For people with commercial insurance coverage, ARS Pharmaceuticals has established a co-pay program to ensure that the out-of-pocket cost for two single-use devices does not exceed $25. Moreover, for individuals without insurance coverage or facing high out-of-pocket expenses, the company plans to offer Neffy at a price of $199 for two doses, with provisions to supply the medicine for free to those who cannot afford it.

Dr. Jonathan Spergel, chief of the allergy program at Children's Hospital of Philadelphia, expressed optimism regarding Neffy, highlighting that the needle-free formulation is expected to prompt swift adoption by those who fear injections, including children. Besides expanding access to immediate treatment, Neffy's nasal spray delivery could facilitate its inclusion in emergency kits on airplanes and in public places like restaurants.

The FDA's approval of Neffy is a significant milestone for individuals who have long waited for a needle-free alternative for anaphylaxis treatment. Experts believe that the availability of this nasal spray epinephrine drug will not only save lives but also address the common hesitation associated with using injectable epinephrine in critical situations.