INP104: a drug evaluation of a nonoral product for the acute treatment of migraine
This drug evaluation, which has been recently published in our partner journal Pain Management, reviews INP104, a novel upper-nasal delivery product combining dihydroergotamine mesylate and Precision Olfactory Delivery (POD®) for fast, well-tolerated migraine relief.
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
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, 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 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.