Impel Pharmaceuticals presented results from the first-ever pharmacokinetic (PK) and pharmacodynamic (PD) evaluation of potential drug-drug interactions (DDIs) between Trudhesa®? (dihydroergotamine [DHE] mesylate) nasal spray (0.725 mg per spray) and orally administered gepant medications. The analysis being presented suggests that no DDIs of clinical concern are theoretically predicted if Trudhesa and gepants are co-administered within recommended clinical doses.

The study authors believe that the PD profiles of DHE and gepants are not anticipated to overlap significantly given their differing mechanisms of action, though potential PD DDIs cannot be completely excluded. Additionally, while first-pass metabolism may limit the bioavailability of orally administered drugs, since Trudhesa is administered via the upper nasal space, it bypasses the gastrointestinal (GI) and hepatic first-pass metabolism. These differing routes of administration may further reduce the potential for interaction.

In a survey of nearly 4,000 U.S. patients using oral acute prescription medication for migraine, 96% said they were dissatisfied with at least one aspect of their treatment--including lack of sustained relief, inconsistent relief, and lack of relief from a rapid-onset attack. Nearly half (48%) said they can still have pain two hours after taking medication and 38% say their headache returns within 24 hours of getting relief.11 Additionally, there is a need for non-oral routes of administration given the high prevalence of gastrointestinal issues among people with migraine. Trudhesa®?

is approved by the FDA for the acute treatment of migraine with or without aura in adults in the U.S. Using Impel's proprietary POD®? technology, Trudhesa gently delivers DHE--a proven, well-established therapeutic8-- quickly to the bloodstream through the vascular-rich upper nasal space. Trudhesa bypasses the gut and potential absorption issues, offering the potential for rapid, sustained, and consistent symptom relief without nausea commonly associated with injection or infusion DHE – even when administered hours after the onset of a migraine attack.