Called Neffy, it is an alternative
to injections and can manage an emergency better.
Neffy’s
FDA approval was based on four studies conducted with 175 healthy adults who
did not have anaphylaxis.
The United States Food and Drug
Administration (FDA) recently approved the first-ever nasal spray for treating
anaphylaxis, a severe and life-threatening allergic reaction that demands
immediate medical attention and an injection of epinephrine, a hormone shot
that fights the allergen.
So now you can replace
these shots and treat the condition painlessly and conveniently with the new
epinephrine nasal spray called Neffy, developed by the US-based ARS Pharmaceuticals. It has been designed for the emergency treatment of Type I
allergic reactions, including those that are life-threatening and are
caused by food, medication and insect bites. This
approval applies to both adults and children who weigh at least 30 kg. The US
FDA has approved the 2 mg version for treatment.
What
is epinephrine?
This is a hormone medication that relaxes
the muscles in the airways and constricts the blood vessels, making it the only
life-saving treatment for anaphylaxis. As an injection, it is administered
alongside emergency medical care to treat life-threatening allergic reactions
triggered by insect bites or stings, foods, medication, latex or other causes.
Why
is the US FDA approval significant?
Dr Pravin Hissaria, Head of Clinical
Immunology and Allergy at Royal Adelaide Hospital, Australia, and a consultant
at Zydus Hospital in Ahmedabad, says Neffy could be transformative
in low- and middle-income countries which lack auto-injectors, compelling
patients to manually draw and administer adrenaline. “Epinephrine
auto-injectors must be kept at a specific temperature and carried in an ice
pack because severe allergic reactions can occur anytime. However, in places
like India, where we need to teach patients how to draw the correct amount of
adrenaline and inject it themselves — a time-consuming process — a nasal spray
could be a game changer,” says Dr Hissaria.
Allergy consultant Dr Raj Bhagat says a
spray could benefit children the most. “They fear injections and they cannot
manually draw and inject adrenaline on their own. Parents also worry about
leaving these children unsupervised because they might develop anaphylaxis and
need precise dosing. An easy-to-use nasal spray could resolve the issue,” he
says.
What’s
the efficacy of Neffy?
Neffy’s FDA approval was based on four
studies conducted with 175 healthy adults who did not have anaphylaxis. These
compared the levels of epinephrine in the blood of subjects after using Neffy
with those who used the traditional epinephrine injections. Neffy delivered
similar levels of epinephrine in the blood as the approved injection products.
Additionally, Neffy had similar effects on increasing blood pressure and heart
rate, which are critical in treating anaphylaxis.
What
is the incidence of severe allergic reactions reported in India?
Dr Hissaria points out that the incidence
of anaphylaxis in India is under-reported, largely because the field is spread
across various medical specialities and there haven’t been enough studies in the
country. “While anaphylaxis caused by venom and medicines is well-known,
food-induced anaphylaxis is becoming more common in India, possibly due to
globalisation and changing lifestyles. So a nasal spray shows great promise,”
he adds.
The three most common allergens are foods
such as nuts, milk, fish, and certain fruits; medications including vaccines,
anti-inflammatories, antibiotics and insect venom, particularly from wasps and
bee stings. Foods affect children more, drugs affect more adults.
No comments:
Post a Comment