Because the FDA authorised neffy™ on Friday, we’ve been inundated with questions from our readers.
To get definitive solutions, we reached out to ARS Prescription drugs — the corporate that developed neffy — to provide us the news.
What’s neffy?
Neffy is an emergency epinephrine machine used to halt and reverse the development of anaphylaxis. Somewhat than ship epinephrine by way of a jab to the outer thigh like conventional auto-injectors, neffy delivers a superb mist sprayed right into a nostril. As such, it’s the first FDA-approved first-line needle-free emergency epinephrine machine.
Is neffy as efficient as an auto-injector?
Sure, neffy was designed to ship epinephrine throughout the vary of injectable merchandise and has demonstrated fast onset and quick time to decision of signs in sufferers with anaphylaxis.
Is neffy efficient if the affected person has nasal congestion?
Neffy is supposed to coat the nasal membranes, to not be inhaled into the lungs. As a result of nasal membranes are sometimes infected with congestion, the drug was truly discovered to be absorbed higher with congestion.
Can neffy be administered if the affected person is unresponsive?
Sure.
When can I start filling prescriptions for neffy?
The corporate hopes to have drug obtainable by their specialty pharmacy and retail pharmacies earlier than the top of September.
Sufferers and caregivers can register now on www.neffy.com by way of neffyConnect early this week.
What’s neffyConnect?
NeffyConnect is a specialty direct-order pharmacy that may fill prescriptions in considered one of 3 ways:
- By receiving a prescription from the affected person’s physician;
- By requesting a prescription from the affected person’s physician;
- By way of a digital doctor that may prescribe neffy for you [available within 3 weeks].
neffyConnect will ship the machine to the affected person/caregiver as quickly because it turns into obtainable, and is at the moment the quickest option to obtain it.
Will the doctor have to prescribe neffy particularly, or will or not it’s fillable with an auto-injector prescription?
Neffy should be particularly prescribed; it can’t be crammed with a prescription for a selected auto-injector. That mentioned, sufferers will have the ability to entry a digital physician by way of neffyConnect who can prescribe Neffy.
What’s the time-to-expiration of the machine?
The machine is manufactured with a 30-month time-to-expiration however as a result of launch testing and distribution, sufferers will obtain neffy with a mean of 24 months remaining, twice that of conventional auto-injectors.
What’s going to neffy value?
The corporate anticipates most individuals with insurance coverage can pay $25 for a two-pack. These with out insurance coverage or with high-deductible plans won’t ever pay greater than $199. Though that is roughly the identical value as that of generic auto-injectors, understand that neffy will final twice as lengthy if not used.
It might take a while for neffy to be added to the affected person’s insurance coverage firm’s formulary requiring prior approval for the fee to be coated by insurance coverage with a co-pay. If ordered by way of neffyConnect, ARS will do the work for the doctor to acquire this prior approval.
What are acceptable temperatures for storage and excursions?
As with all drugs, Neffy must be saved at room temperature. Nevertheless, the labeling permits for excursions as much as 122°F (50°C). So if neffy is by chance left in a scorching automobile for the day it must be superb.
Whereas neffy states “Don’t Freeze,” if by chance frozen — which happens beneath 5° F — it is not going to harm the product or machine, however will take about 20 minutes to thaw. The machine is not going to work till totally thawed. Not like an auto-injector, freezing doesn’t harm the treatment or the machine.
How is neffy packaged?
Neffy is blister-packaged in a two-pack. Sufferers will have the ability to request a protecting case from ARS. [See image above on lower right.]
When is FDA approval of neffy for youngsters lower than 30kg anticipated?
ARS anticipates submitting for a 1mg dose for youngsters 15-30kg inside a month adopted by the FDA taking as much as 6 months to approve. The European Medical Company and ARS are working towards a dosage for youngsters lower than 15kg which may take 2-3 years.
