Phase 3 Data Show Fast Relief of Migraine with OptiNose Sumatriptan Treatment
OptiNose US announced that the Phase 3 TARGET study successfully met its primary endpoint, finding the new 16mg OptiNose sumatriptan product provided headache relief for 68% of patients with moderate to severe migraines after two hours (P<0.01 vs. placebo). OptiNose's Bi-Directional nasal medication delivery technology is designed to improve delivery to difficult-to-reach target sites deep in the nose. Sumatriptan is a selective 5-HT1B/1D receptor agonist.
In this multicenter, double-blind, placebo-controlled study, migraine sufferers were randomized to self-administer either OptiNose sumatriptan or placebo using the OptiNose device when they had moderate to severe migraine pain. Pain scores were then assessed at various time points after administration. Pain was evaluated using a four point scale with headache relief defined as a reduction from moderate (Grade 2) or severe (Grade 3) pain to mild (Grade 1) or complete relief (Grade 0). The data show pain relief for some patients began as early as 15 minutes after treatment, and a statistically significant greater number of patients receiving OptiNose sumatriptan experienced headache relief compared to placebo at all times from 30 minutes through two hours. At two hours after taking the medication, 7 out of 10 patients taking OptiNose sumatriptan reported that they were experiencing meaningful relief from their headache pain.For more information visit www.optinose.com.