A unique aspect of emergency medicine is being on the front lines of clinical care. We are fortunate to be among the first to be exposed to all things, from novel respiratory pathogens to newly approved pharmaceuticals. Here are a few of the new approvals potentially relevant to emergency medicine practice.

Neffy

First off the rack is Neffy (epinephrine), whose name is more reminiscent of a child’s plush toy than a pharmaceutical. Regardless, Neffy is approved as an intranasal delivery system for epinephrine primarily for the treatment of anaphylaxis. The marketing pitch focuses on the intranasal route as an alternative to needles required for intramuscular administration.

However, it is worth noting that the approval for Neffy did not involve any patients treated for actual anaphylaxis. Rather, the approval hinged on pharmacokinetic evaluation conducted in healthy volunteers.¹ In the “pivotal” study relied upon for FDA approval, two milligrams of nasal Neffy was administered and compared with 0.3 mg of epinephrine administered intramuscularly either by needle and syringe or by cartridge auto-injector.²

According to the pharmacokinetic data presented, Neffy showed serum epinephrine levels exceeding that of both methods of intramuscular administration, and thus, its approval.

However, within the first 30 minutes, arguably the most important time frame for treatment of anaphylaxis, Neffy had a much slower onset and reached a lower peak plasma concentration than the epinephrine auto-injector. It was only when serum levels were measured all the way out to the six-hour mark did Neffy catch up and surpass its comparators. Although it may be true Neffy is a “potential alternative” to epinephrine injectables, its lack of documented real-world effectiveness is a major limitation. Finally, Neffy is estimated to have a wholesale acquisition cost of about $700 for a twin-pack device, a bit more than even the already-quite-expensive branded auto-injectors.³

Journavx

The quest for safe, non-opioid pain relief continues with Journavx (suzetrigine). This medication is a first-in-class analgesic with a mechanism of action featuring selective inhibition of peripheral sodium channels. Naturally, Journavx is far from a miracle drug with immediate application to emergency medical practice, but it may have a limited role.

Efficacy for Journavx was demonstrated primarily in two clinical trials following minor surgical procedures in healthy adults.⁴ In each of these, Journavx was tested against both placebo and a combination of hydrocodone and acetaminophen. In the first trial, conducted in patients undergoing abdominoplasty, Journavx demonstrated apparent efficacy on the level with the hydrocodone and acetaminophen combination arm. In the second trial, in patients undergoing bunionectomy, there was no difference between Journavx and placebo until the eight-hour mark after study initiation.