Impel Pharmaceuticals presented results from the first-ever pharmacokinetic and pharmacodynamic evaluation of potential drug-drug interactions between Trudhesa nasal 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 and hepatic first-pass metabolism. These differing routes of administration may further reduce the potential for interaction. "We have previously shared data supporting the benefits of Trudhesa as a safe and effective treatment that provides rapid and sustained relief and, importantly, can be taken at any time within a migraine attack. These analyses shed some light on the potential safety profile of Trudhesa when prescribed concomitantly with certain other widely used migraine therapeutics," said Sheena Aurora, M.D., Vice President Medical Affairs, Impel Pharmaceuticals. "Cumulatively, the data we’ve shared showcase Trudhesa’s potential to address unmet needs for patients who may have lack of efficacy with the oral gepants by providing a reliable option that can be used for headaches accompanied by nausea and/or vomiting and multiple types of difficult-to-treat migraines. The unique mechanism administering DHE to the upper nasal space further stands to position Trudhesa as a valuable resource for effective migraine relief."
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