FDA accepts new drug application for intranasal migraine treatment INP104
The FDA accepted a new drug application for INP104 for the acute treatment of migraine with or without aura in adults, Impel NeuroPharma announced.
INP104 delivers dihydroergotamine mesylate directly into the upper nasal space using Impel NeuroPharma’s precision olfactory delivery, or POD, technology.
The company based the NDA submission for INP104 on results from the phase 3 STOP 301 study, which comprised 360 patients with a diagnosis of migraine with or without aura who experienced at least two attacks per months in the preceding 6 months. In the trial, which was conducted at 36 sites in the United States, researchers administered at least one dose of INP104 to 354 patients; these patients comprised the full safety set, according to the press release. The primary safety set included 185 patients who received an average or two or more treatments with INP104 per 28-day period over the course of the 24-week treatment period.
The researchers treated more than 5,650 migraine attacks over 24 or 52 weeks, according to the press release. The STOP 301 study achieved its primary objectives, with no new safety signals or “concerning trends” in nasal safety findings with INP104 after administration of dihydroergotamine mesylate. Most treatment-emergent adverse events in the full safety set were mild and transient, according to the press release. The most common treatment-emergent adverse events, occurring in 5% or more of the study population during the 24-week treatment period, included nasal congestion (16.7%), nausea (7.9%), nasal discomfort (5.4%) and abnormal taste (5.1%).
Study results showed no cardiac treatment-emergent adverse events and no significant changes in mean heart rate over 24 weeks of treatment. Additionally, no drug-related serious adverse events occurred in the full 52-week study period.
Exploratory patient-reported efficacy data from the full safety set showed that 66.3% of patients reported pain relief, 38% reported pain freedom and 52% experienced “freedom from their most bothersome migraine symptom” 2 hours after the first dose of INP104. Further, in 85% of migraine attacks that were documented, patients did not report use of rescue medications. Initial onset of pain relief improved over the course of the study.
The FDA set a PDUFA date of Sept. 6, 2021, for INP104. If approved, INP104 would be marketed under the trade name Trudhesa in the United States and would become the first therapy to use POD technology, according to the press release.
Impel NeuroPharma. Impel NeuroPharma announces U.S. Food and Drug Administration acceptance of new drug application for INP104 for the acute treatment of migraine. Available at: https://impelnp.com/2021/01/20/impel-neuropharma-announces-u-s-food-drug-administration-acceptance-of-new-drug-application-for-inp104-for-the-acute-treatment-of-migraine/. Accessed Jan. 21, 2021.