Nasal spray alternative to EpiPen faces setback as FDA seeks fresh study (updated)

ARS Pharmaceuticals

20/09/2023 15:31

(Updates shares in paragraph 1 and 14, comments from a parent
in paragraph 11, 12)
    By Sriparna  Roy and Jahnavi Nidumolu
       Sept 20 (Reuters) - The U.S. health regulator has
declined to approve a nasal spray that would have been the first
needle-free emergency treatment for allergic reactions, a
surprise decision that pushed shares of its developer ARS
Pharmaceuticals  SPRY.O  to a record low.
    The rejection and request for additional testing sharply
contrasts the backing from the independent experts of the U.S.
Food and Drug Administration (FDA) for the spray, neffy, in May.
    ARS Pharma said on late Tuesday the FDA has sought a
repeat-dose study of the treatment versus a rival injected
product before a potential approval instead of after, as was
mutually agreed in August.
    The company said it was "very surprised" and will appeal the
decision. 
    "Regulators look to be holding neffy to a much higher
standard than comparable products," said William Blair analyst
Tim Lugo, adding regulatory risks look difficult to assess. 
    EpiPen-maker Viatris  VTRS.O  had in June petitioned the FDA
to require that ARS conduct more trials that closely mimic
real-world conditions.
    Neffy is seen as an alternative to EpiPen and other
autoinjectors like Kaleo's Auvi-Q that are filled with
epinephrine, a life-saving drug used by people at risk of
anaphylaxis and other allergic reactions.
    ARS' application was based on trials in healthy patients and
those having a rhinitis attack, with the spray showing a
comparable response to injectable products.
    It did not test neffy in anaphylaxis, a severe,
life-threatening allergic reaction, due to ethical concerns. 
    The lack of tests in people with anaphylaxis was one of the
biggest concerns, said James Tarbox, an allergist at Texas Tech
University Health Sciences Center.
    "I think that anything new takes time to build trust," said
Lianne Mandelbaum, a parent of a child with food allergies that
Reuters contacted through ARS Pharma. 
        "I would begin carrying it (neffy) immediately, it is
not to say that I would get rid of my auto injectors so quickly,
but hopefully over time this would be our standard of care
treatment choice." 
  
    ARS expects to re-submit its application in the first half
of 2024, with an FDA decision likely in the second half. 
    Its shares were down at $2.86 in early trading on Wednesday.

 (Reporting by Christy Santhosh, Sriparna Roy and Jahnavi
Nidumolu in Bengaluru; Editing by Sriraj Kalluvila and Arun
Koyyur)
 ((Christy.Santhosh@thomsonreuters.com;))