FDA Pauses Approval of Needleless Epinephrine Spray

In a turn of events that caught many by surprise, the U.S. Food and Drug Administration (FDA) has put a pause on the approval of a groundbreaking epinephrine nasal spray. This spray, named Neffy, was poised to be the inaugural non-injectable counterpart to the widely used epinephrine autoinjectors, like EpiPens. 

As reported by NBC News, ARS Pharmaceuticals, the brains behind Neffy, received feedback from the FDA suggesting the need for more comprehensive research before granting approval. This decision is particularly intriguing because, earlier in May, an FDA advisory committee had given a nod for the drug’s use in both adult and pediatric populations. 

The CEO of ARS Pharmaceuticals, Richard Lowenthal, didn’t hide his astonishment at the FDA’s stance. He signaled the company’s intention to contest the FDA’s call for supplementary data. 

Epinephrine has stood the test of time, being a pivotal remedy in the U.S. for over a century. Its prowess in reversing the life-threatening allergic reaction, anaphylaxis, is well-documented. However, the current treatment landscape only offers injectable solutions, which isn’t ideal for those with an aversion to needles. 

The medical community, including Dr. Zachary Rubin, an Illinois-based allergist, has been vocal about the pressing need for a non-injectable epinephrine solution. The advisory committee’s discussions in May did bring to light some gaps, notably the absence of trials involving individuals in the throes of anaphylaxis. 

While ARS Pharmaceuticals presented data suggesting Neffy’s efficacy was in line with EpiPens, these findings were primarily from animal studies and tests on humans not facing an anaphylactic episode. Despite these gaps, the committee had leaned towards endorsing the drug. 

Dr. Maryann Amirshahi, a committee member, pinpointed the lack of anaphylaxis patient data as a concern. She underscored the potential perils of relying on a treatment that might falter when it matters most. The ethical implications of testing an emergency drug are manifold.

However, Dr. Amirshahi believes that under controlled conditions, such as in a specialist’s clinic or an ER, these trials could be feasible. In the latest directive, the FDA has sought a comparative study between Neffy and traditional epinephrine autoinjectors, with a focus on symptoms induced by allergens. With plans to revisit their FDA application in 2024, ARS Pharmaceuticals remains hopeful.