A nasal spray that could save the lives of thousands of people with severe allergies will undergo further testing amid concerns about its effectiveness.
In the UK and countries around the world, people suffering from life-threatening allergies must carry disposable auto-injectors, better known by the brand name EpiPen.
The device delivers the drug epinephrine, a purified form of adrenaline that is essential in treating potentially life-threatening allergic reactions, also known as anaphylactic shock.
Severe allergic reactions are becoming more common. Hospital admissions for food-related anaphylaxis, often caused by nut allergies, have more than doubled, from less than 2,000 people 20 years ago to more than 5,000 people last year.
There were high hopes for a new product called Neffy, developed by the pharmaceutical company ARS Pharma. This product is intended to replace single-use epinephrine injections with an easy-to-use nasal spray.
Decrease in effectiveness
Allergy groups have been campaigning for jab-free options for years to make emergency medicines easier to carry and remove hesitancy and anxiety about administering them for both users and bystanders.
But the product was rejected this week by the powerful US Food and Drug Administration (FDA), citing concerns that while it is more available, it may not be as effective.
The drug’s manufacturer says the FDA has determined that further research is needed. There were concerns that nasal congestion could make the spray less effective, and there were concerns about how long it would take to take effect.
A lack of data on patients with anaphylaxis was also an obstacle for some advisory committees. This is because EpiPen’s blood epinephrine concentration is reached in 5 to 10 minutes, but Nephy’s blood epinephrine concentration is reached only in about 20 minutes.
“The scary thing isn’t the injection, it’s the drug’s failure to treat a life-threatening condition,” said one FDA adviser.
Richard Lowenthal, co-founder, president and CEO of ARS Pharma, said in response to the rejection: “We are extremely disappointed that this action will further delay the availability of Nephi to millions of people who are at potentially life-threatening risk.” allergic reaction.
“Patients and caregivers are waiting for Nephi, and we aim to complete the newly requested trials as quickly as possible to meet the needs of our patients.”
The ruling blocking the drug came despite an FDA advisory committee resolution in May recommending approval of the drug for children and adults. The FDA rarely rejects drugs recommended by a committee.
ARS announced that it will conduct new studies requested by the FDA and resubmit its application in the first half of 2024.
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