The safety of new migraine drugs in phase 3 reached the clinical end point
Last Update: 2020-06-19
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Imper neuropharma today announced the positive results of the critical phase 3 clinical trial stop301The study included 5650 patients with migraine attacks and evaluated the changes in migraine indicators reported by patients compared to the baselineThe study reached the primary clinical end point< br / > in the past, dihydroergotamine mesylate was often used in the treatment of migraineAlthough very effective, it has dose-related side effects and is not easy to useImper neuropharma uses its proprietary pod ® technology to deliver drugs through the vascular rich upper nasal cavityIts product inp104 is dihydroergotamine mesylate administered in this wayIt can deliver low dose dihydroergomethylamine mesylate into the body for treatment< br / > theoretically, the side effects of the drug are expected to be reduced at a lower dose< br / > in this phase 3 clinical trial, the dose used by the researchers was 1.45 mg, 72.5% of the currently approved dose (2.0 mg)< br / > the main objective of this study was achieved and no new safety signals were observed after intranasal administrationIn the 24 week full safety set, the main treatment-related adverse events were mild and short-termThe most common adverse events were nasal obstruction (15.0%), nausea (6.8%), nasal discomfort (5.1%) and taste discomfort (5.1%)Most of the patients completed the study at 24 weeks (74%) and 52 weeks (90%)No drug-related serious adverse events (SAE) were observed throughout the 52 week study period< br / > exploratory efficacy data showed that 66.3% of patients achieved pain relief 2 hours after the first administration of inp104, 38% of patients achieved no painAll in all, these results indicate that snd is expected to provide an effective, consistent and well tolerated alternative to acute oral and injection therapy < br / > the follow-up data analysis of this test is still in progress It is planned that imper neuropharma will submit an NDA listing application in the second half of this year References:  Impel NeuroPharma Announces Primary Objectives Met In Pivotal Phase 3 Registration Study Of INP104 For The Treatment Of institute graduate, retrieved June 10, 2020, from
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