ARS Pharmaceuticals hit with surprise FDA rejection for epinephrine nasal spray Neffy, vows to appeal
20 Sep 2023
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Source: FiercePharma
ARS Pharmaceuticals’ share price plummeted on the news of the FDA rejection. It was trading down about 56% Wednesday morning.
Positive FDA advisory committee votes aren’t always a blueprint for approval. ARS Pharmaceuticals learned that lesson the hard way Tuesday, after the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy.
The FDA has slapped down Neffy, also known as epinephrine nasal spray, to treat type I allergic reactions, including anaphylaxis for adults and children, ARS said in a press release. Given that the drug passed muster at a recent meeting of the FDA’s Pulmonary-Allergy Drugs advisory committee (PADAC), ARS plans to submit a formal dispute resolution request to appeal its complete response letter (CRL).
The FDA is asking ARS to provide more study data on repeat doses of Neffy compared to repeat doses of injectable epinephrine for allergen-induced allergic rhinitis conditions, ARS said.
PADAC in May voted to approve Neffy without the need for additional efficacy or safety studies, the company points out.
In another blow to ARS, the company had already aligned with the FDA in August on final labeling and a post-marketing study plan.
“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, co-founder, president and CEO of ARS Pharma, said in a statement.
Some analysts, such as William Blair’s Tim Lugo, agreed with the company. In a note to clients, Lugo wrote that because of prior interactions with the FDA and the positive advisory committee vote, “this decision comes as a surprise.”
The study requirements are poised to “complicate what has already been a long development process,” Lugo added.
“It does raise questions of whether the agency really wants to approve the therapy, as the pathway has already far exceeded epinephrine products such as EpiPen,” he continued.
Because ARS already agreed to a repeat-dose study as a post-marketing condition, the company expects to resubmit its Neffy application in the first half of 2024, which would set it up for an FDA decision in the second half of next year.
With expectations to have roughly $195 million in cash on hand at the time of the anticipated launch, ARS is “well capitalized to endure the delay,” William Blair’s Lugo said.
ARS Pharmaceuticals’ shares have plummeted on the news. The company’s stock price was down about 56% Wednesday morning.
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