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Abstract
Migraine is a highly prevalent, disabling neurological disorder that is also associated with gastrointestinal symptoms, autonomic dysfunction and allodynia. Despite the availability of multiple acute agents for migraine, an unmet need remains for effective, well-tolerated drugs that are nonoral and noninvasive. Here, we provide a drug evaluation of INP104, a novel drug-device combination product of dihydroergotamine (DHE) mesylate – a molecule with a long history of efficacy familiar to headache specialists – which is delivered to the difficult-to-reach upper nasal space where it is rapidly and consistently absorbed via Precision Olfactory Delivery (POD®). In clinical trials, INP104 exhibited favorable pharmacokinetics, a well-tolerated safety profile, and rapid symptom relief, highlighting its potential as a suitable acute therapy for migraine.
Plain Language Summary
INP104: a drug evaluation of a nonoral product for the acute treatment of migraine
Migraine is a very common headache disorder that often presents with pain and gastrointestinal symptoms. There are many available treatments for migraine, but some patients still need an option that works well for them, that is noninvasive, or does not need to be taken orally. Here we provide a drug evaluation of INP104, an approved acute treatment for migraine that combines a drug and a device: the medication dihydroergotamine (DHE) mesylate, which has been used for decades for treating acute symptoms of migraine, and the Precision Olfactory Delivery (POD®) device, which delivers DHE mesylate to the hard-to-reach upper regions of the nose. Targeting this region helps medication to be absorbed faster and more consistently. In clinical trials, INP104 demonstrated favorable drug properties, came with few adverse events, and provided fast relief from migraine symptoms.
Tweetable abstract
There remains a need for more effective migraine therapies. INP104 is a novel upper-nasal delivery product combining dihydroergotamine mesylate and Precision Olfactory Delivery (POD®) for fast, well-tolerated migraine relief.
Acknowledgments
The authors were fully responsible for the content, editorial decisions, and opinions expressed in the current article.
Financial & competing interests disclosure
This study was fully funded by Impel Pharmaceuticals Inc. Amaal J. Starling has received consulting fees from AbbVie, Allergan, Amgen, Axsome Therapeutics, Eli Lilly & Company, Everyday Health, Impel Pharmaceuticals, Lundbeck, Med-IQ, Medscape, Neurolief, Novartis, Satsuma Pharmaceuticals, Teva Pharmaceuticals, and Theranica. Theresa Mallick-Searle has served on speaker bureaus for Averitas Pharma, Impel Pharmaceuticals, and Salix Pharmaceuticals. Stephen B. Shrewsbury was a former full-time employee and an officer of Impel Pharmaceuticals during the development of this manuscript. He remains a stockholder. Sheena K. Aurora is a full-time employee of Impel Pharmaceuticals and is a stockholder in Impel Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Medical writing support was provided by Veronika Khariv, PhD, from IMPRINT Science, New York, NY, USA, and was funded by Impel Pharmaceuticals Inc.