Migraine Drug Meets Primary Endpoint in Phase 3 Trial
Avanir announced that the COMPASS trial met the primary efficacy endpoint in the assessment of AVP-825.
COMPASS is a Phase 3 multicenter, randomized, double-blind, double-dummy crossover trial that compared the efficacy and safety of AVP-825 22mg to sumatriptan 100mg tablets for the treatment of acute migraines in adults. The primary endpoint for the sum of pain intensity difference at 30 minutes post dose (SPID30) was met, showing that patients achieved greater pain relief within 30 minutes of treatment with AVP-825 22mg than with sumatriptan 100mg tablet (P<0.0001).
Also, patients treated with AVP-825 achieved pain relief in a greater proportion of migraine attacks at 15, 30, 45, 60 and 90 minutes post dose compared with those treated with sumatriptan (P<0.05). Several additional secondary endpoints relating to pain relief were also met.
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered delivery technology.
For more information call (855) 468-3339 or visit Avanir.com.