FDA Accepts New Drug Application for New Dihydroergotamine Formulation for Acute Treatment of Migraine

The Food and Drug Administration (FDA) has accepted the new drug application (NDA) for a new formulation of dihydroergotamine (DHE) (inp104; Trudhesa; Impel Neuropharma, Seattle, WA) for the acute treatment of migraine with or without aura. If approved, this formulation of DHE will be the first therapy administered via point of delivery (POD) technology that targets the vascular-rich upper nasal space.

The pivotal phase 3 STOP 301 study (NCT03557333) supported the submission for the NDA based on the safety results. In the study, more than 5,650 migraine attacks were treated over 24 or 52 weeks. Exploratory patient-reported efficacy data reported 66.3% of participants experienced pain relief, 38% of participants reported pain freedom, and 52% had freedom from their most bothersome migraine symptom (MBS) at 2 hours. In 85% of reported migraine attacks, participants did not use rescue medication. Of participants, 16.3% started initial onset of pain relief as early as 15 minutes. This continued to improve over time. The STOP 301 study for DHE is currently 1 of the largest longitudinal studies of migraine.

“The FDA’s acceptance of our submission package for Trudhesa marks another important step in our journey to bring an important new treatment option to patients who, despite recThe Prescription Drug User Fee Act (PDUFA) target action date, set by the FDA, is September 6, 2021.