The FDA’s Pulmonary-Allergy Drug Advisory Committee voted 16-6 in favor of ARS Pharmaceuticals Inc’s (NASDAQ: SPRY) neffy in treating severe allergic reactions for adults (and 16-5 for children who weigh over 30kg).
Before the Adcomm meeting, the FDA reviewers raised some concerns regarding Neffy, an intranasal epinephrine product.
“Relying on PK/PD raises multiple uncertainties as there are notable differences in PK/PD results between epinephrine injection and ARS1,” the FDA said. And while single and repeat dose studies “did not raise safety concerns,” the FDA still said, “it is uncertain if there would be adverse events, particularly local adverse events, from frequent use.”
“We believe our clinical data from more than 600 individuals demonstrate neffy’s absorption-enhancing nasal spray technology is comparable to injectable products in delivering potentially lifesaving epinephrine, but with unique advantages of being small, needle-free, and conveniently sized,” said Richard Lowenthal, Co-founder, President & CEO.
The company said that with neffy, blood pressure and heart rate are comparable to EpiPen with a single dose – and with a second dose of neffy, increases in systolic blood pressure were statistically higher, even better than revealed in the available data from EpiPen.
