Full enrollment has been reached for STOP-301 (NCT03557333), a phase 3 open-label study of dihydroergotamine (DHE) delivered to the upper nasal cavity. In this study, drug delivery is achieved with a new and novel type of nasal pump. The investigational drug-device combination (INP104; Impel NeuroPharma, Inc., Seattle, WA) uses a precision olfactory delivery device (POD) to deliver drug to the upper nasal cavity. Advantages of upper nasal cavity drug delivery include higher density vasculature, higher permeability, and a reduced clearance rate compared with deliver to the lower nasal cavity. In clinical trials drugs have been rapidly absorbed with consistent biodistribution.
Currently used with intravenous (IV) delivery, DHE is highly effective for acute treatment of migraine. The STOP-301 trial will evaluate the safety of long-term, intermittent use of the drug-device treatment over 1 year, and will collect efficacy data as assessed by the change from baseline in migraine measures.
A total of 360 participants are enrolled, and a subset of 73 patients will continue into a 28-week treatment-extension period and a 2-week posttreatment follow-up period.
Stephen B. Shrewsbury, MD, chief medical officer, Impel NeuroPharma, said, “INP104 has the potential to provide IV-like DHE effects in the home with rapid onset and long-lasting benefits because it reaches the vascular-rich upper nasal cavity, an emerging new area of the body for drug administration. Although the use of DHE has been limited due to route of administration, it remains a trusted treatment for acute migraine in headache clinics. Importantly, because INP104 is designed to provide consistent delivery of DHE, it can be used anytime and anywhere. We look forward to sharing the top-line results of STOP-301 in early 2020."