FDA declines to approve nasal spray alternative to EpiPen, company says
Regulators at the U.S. Food and Drug Administration declined to approve a needle-free nasal spray equivalent to an EpiPen, pending further study, according to the company developing it.
ARS Pharma developed the product, Neffy, which is inhaled and would have been available by prescription if approved.
Neffy would be a first-of-its-kind alternative to an EpiPen, which is commonly used to treat anaphylaxis, or severe allegoric reactions.
The FDA said they haven't yet seen enough evidence to support approval. The company will have an opportunity to run additional studies and apply for approval again.
'We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote," Richard Lowenthal, CEO of ARS, said in a statement on Tuesday.
ARS shares fell sharply, dropping about 58% in pre-market trade on Wednesday morning.
This is a developing story. Please check back for updates.