United States – Those who used to always be nervous every time they were required to give a rescue shot for anaphylaxis will now have a new option in a nasal spray.
FDA Endorses Neffy
The U.S. FDA on Friday disclosed that it has endorsed Neffy, the foremost non-injected therapy for life-threatening allergic reactions.
The epinephrine nasal spray is for use by people who weigh more than 66 pounds, both children and adults, the agency said.
A Solution to Overcome Treatment Hesitation
“Anaphylaxis is fatal, and some patients, specifically children, out of sheer pity may decline treatment out of such fear,” Dr. Kelly Stone, the associate director of the Division of Pulmonology, Allergy, and Critical Care at the FDA Center for Drug Evaluation and Research said in an FDA release. “The expanding use of epinephrine nasal spray may lower the challenges of early management of anaphylaxis. Stanimirovic notes that Neffy is a relevant treatment solution that meets the demand.
Allergy sufferers may have an acute, terrifying episode caused by allergens, which, in most cases, include certain foods, medications, or insect stings.
How Neffy Works
Prior to this, the only form of rescue medication when such situations happen has been epinephrine, and it is only available in an injectable form.
Neffy was developed by ARS Pharmaceuticals and is applied in the form of a nasal spray that is sprayed into one of the nostrils, according to the FDA. If relief is not achieved after the first dose, the agency encourages administering a second dose from a new dispenser into the same nostril. Keep an eye on the patient after epinephrine administration to determine whether he /she needs additional treatment or seek medical assistance.
“Neffy’s approval is based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products,” the FDA said. “Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products.”
The studies also revealed that neffy was able to produce the rises in blood pressure and heart rate necessary for anaphylaxis treatment.
Neffy, manufactured by ARS Pharmaceuticals, is an injectable delivered in the form of a spray that is sprayed into one nostril, according to the FDA. In case to alleviate the symptoms, the agency encourages to give the second dose from a new dispenser into the same nostril. Be attentive to the patient once the epinephrine has been administered, as more treatment or seeking for emergency medical attention may be required.
“The FDA said that the approval of Neffy was derived from four trials in 175 healthy adults, without anaphylaxis, where blood levels of epinephrine was analysed after the use of Neffy or other approved epinephrine injection products,” said the FDA. Studies conducted on neffy and approved epinephrine injection products gave similar epinephrine blood concentration figures.
Path to Approval
The new approval was granted after an expert panel encouraged the use of neffy back in May of 2023. Finally, in September, the FDA sort of halted its approval of the device by requesting more research to be done.