The Food and Drug Administration (FDA) decided to reject the first needle-free alternative to EpiPens.
FDA officials claim that this new medicine product needs further research before they can support the approval.
FDA Claims Needle-Free Alternative to EpiPens Need Further Research
Timothy Lunceford Stevens, who suffers from autoimmune diseases and allergies, holds an EpiPen as he speaks to reporters during a protest against the price of EpiPens, outside the office of hedge fund manager John Paulson, August 30, 2016 in New York City.
ARS Pharmaceuticals, the drug maker behind Neffy-the first needle-free alternative to epinephrine autoinjectors-was surprised by FDA's rejection.
This is because the FDA Advisory Committee (PADAC) was the one that voted to recommend approval of the Neffy drug back in May.
This approval was supposed to allow Neffy to be used by both adults and children. Health experts said that this is a rare case since the FDA usually approves products that have been recommended by its own committees.
"We are very surprised by this action," said ARS Pharmaceuticals CEO Richard Lowenthal via NBC News.
Aside from Lowenthal, other Americans also questioned the decision of the FDA to reject Neffy. One of them is Dr. Zachary Rubin of Oak Brook Allergists in Illinois, saying that he was shocked.
"You basically have epinephrine autoinjector devices, needle options, and people have been clamoring for years to get a needle-free option," he said.
As of press time, FDA officials want ARS to conduct additional studies on the first needle-free EpiPen alternative. But, the drug maker now plans to appeal the FDA's request for additional research.
What FDA Specifically Asks For
A 2-pack of EpiPen is seen on the witness table during a hearing before the House Oversight and Government Reform Committee September 21, 2016 on Capitol Hill in Washington, DC. The committee held a hearing on "Reviewing the Rising Price of EpiPens."
According to Globe News Wire's latest report, the FDA issued a CRL (Complete Response Letter) regarding the NDA (New Drug Application) for Neffy.
The health organization said that it wants ARS to provide a completed pharmacokinetic/pharmacodynamic study assessing repeat doses of the needle-free EpiPen alternative.
They want to have this so they can compare if Neffy is really as effective (or more efficient) as existing epinephrine autoinjectors. This request contradicts the recent decision of PADAC, which recommended the drug's approval without the need for further studies.
Recently, ARS Pharmaceuticals already conducted numerous studies involving animals and human subjects who don't have anaphylaxis.
Based on their findings, Neffy, a nasal spray drug, is comparable to an EpiPen. The creation of this first needle-free EpiPen alternative is a big deal for many people with extreme allergies, especially children.
Dr. Maryann Amirshahi, one of the members of the FDA's Advisory Committee, said that he heard some parents talking about how traumatic it was for their children to use epinephrine autoinjectors.
However, Amirshahi explained that the scary thing is not really taking a shot of EpiPen and other similar drugs. What's scary is when the medicine fails to treat a life-threatening condition.
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