FDA rejects first nasal spray alternative to EpiPen for those with severe allergies

ARS Pharmaceuticals revealed late Tuesday evening that the FDA rejected what would have been the first epinephrine nasal spray.

The FDA requested another pharmacokinetic/pharmacodynamic study assessing repeat doses of the nasal spray, which would have been known as neffy, compared to repeat doses of an epinephrine injection under allergen-induced allergic rhinitis conditions to support approval. ARS said it will file a formal dispute with FDA, which is usually a last-ditch effort to sway the agency.

“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, president and CEO of ARS Pharma, said in a statement. Shares of ARS stock fell by more than 45% premarket Wednesday.

“In fact, multiple Committee members highlighted the favorable profile of neffy in our completed single-dose nasal allergy challenge study and that any decline in exposure 20 minutes after dosing, after the expected response period, is of no concern,” he added.

ARS planned to set a list price of $199 for neffy although the company was ready to promise that most people with commercial insurance won’t pay more than a $25 co-pay.

While the new nasal spray now isn’t likely to see significant uptake for at least another six months to a year, some are still hoping for an EpiPen alternative.

“The real opportunity here is patients don’t have to have the hesitation to use it because it will hurt,” Anne Ellis, clinician-scientist at Queens University in Canada and a member of the ARS scientific advisory board, explained to Endpoints News in an interview. She noted that a number of nasal allergen challenges for the spray showed that it’s still effective even in the setting of nasal inflammation.

The FDA’s Pulmonary-Allergy Drugs Advisory Committee in May voted 16-6 in favor of neffy for adults and 16-5 in favor for children who weigh at least 66 pounds.

But multiple adcomm members questioned the nasal spray’s benefit-risk profile, calling for some clinical data on the nasal spray to be produced before it can be approved. Others questioned whether a smaller clinical study might be enough.

Ellis noted that no randomized, clinical data were submitted to the FDA when the EpiPen first won approval.

“What the company has done is a whole lot of studies looking at serum levels of epinephrine following the use of the neffy device, and comparing that to EpiPen as well as just needle and syringe with epinephrine in it,” Ellis said. “And they’ve been able to show very comparable pharmacokinetic properties.”

Richard Lowenthal

Lowenthal told Endpoints in an interview that the company had to conduct studies that were ethical. He noted the company’s market research shows that there are between 16 million and 20 million Americans who have to deal with these types of allergic reactions, and between 60% and 80% of the current autoinjector users will probably switch to the nasal spray.

“Will neffy be used in hospitals? I’m not sure,” Lowenthal said. “But because it’s so much easier to use and more convenient,” he says it could move in the same direction as the Narcan nasal spray for opioid overdoses. “The primary focus, at least initially, is in communities,” he added.

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