After this point, Journavx “caught up” with the hydrocodone and acetaminophen combination arm. The slow onset of effectiveness suggested by these data is consistent with the pharmacokinetics of Journavx, and implies there will not be any role for Journavx in controlling acute pain. However, there may be a role for this drug in patients whose painful conditions are expected to persist for several days after emergency department discharge.

It is important to note Journavx is metabolized through the CYP3A pathway, producing the potential for many drug-drug interactions. Dosing adjustment is suggested in patients already taking CYP3A inducers. Conversely, Journavx is contraindicated in patients taking CYP3A inhibitors, as concomitant use would increase serum exposures.

The wholesale acquisition cost for Journavx is estimated at about $460 for a 30-count bottle.⁵

Atzumi

Going from new drugs to old drugs, Atzumi (dihydroergotamine [DHE]) tries yet again to revive the very old drug dihydroergotamine. Ergotamine-formulation medications have been used to treat migraines for nearly 100 years. In fact, nasal spray administration of DHE has been available on the market since 1946. The challenge with DHE-based intranasal medications, traditionally, has been their limited effectiveness because of low bioavailability from the anterior nasal route.

Atzumi is preceded by the 2021 approval of Trudhesa, also a DHE product featuring a new delivery system. Trudhesa improved on the 1946 standard by targeting the upper nasal passages for improved absorption.⁶ In its particular variation, Atzumi repackages the DHE into a powder-based form. Based on the clinical trials leading to its approval, this powder-based delivery attains bioavailability of approximately 60 percent, similar to the Trudhesa product.⁷

The DHE are also metabolized through the CYP3A pathway, resulting in a wide spectrum of potential interactions. The consequence of potentiated vasoconstriction is obvious: peripheral limb ischemia, myocardial infarction, and fatal cerebrovascular complications.⁸ In addition to CYP3A concerns, there are several other classes of medications thought to have the ability to potentiate vasoconstriction and vasospasm, including triptans, selective serotonin reuptake inhibitors, nicotine, and certain beta-blockers. It is unlikely this will ever be a preferred option to initiate in the emergency department. Rather, if there is sufficient uptake of these two medications, presentations for their adverse effects may become more common.

Wholesale acquisition cost for Atzumi was not available at the time of this writing, but it is expected to be similar to Trudhesa at about $850 for a four-dose kit.