[I9-2.002] Efficacy and Safety of AVP-825, a Novel Breath-PoweredTM Powder Sumatriptan Intranasal Treatment, for Acute Migraine
Roger Cady,1John Messina,2Jennifer Carothers,2Ramy Mahmoud2
1Springfield, MO, USA, 2Yardley, PA, USA
OBJECTIVE: Evaluate efficacy and safety of AVP-825 vs. placebo in patients with moderate-to-severe migraine headache.
BACKGROUND: Patients taking oral triptans commonly cite slow onset of action, inconsistent pain relief, and adverse effects (AEs) as reasons for dissatisfaction. Adverse effects known as “triptan effects” are associated with formulations and doses that produce higher plasma levels. In a Phase II trial, AVP-825 (low dose sumatriptan powder delivered intranasally using a novel Breath-Powered device) produced onset of headache relief at speeds approaching that previously reported with injections, without similarly high AE rates. A larger Phase III trial is reported here.
DESIGN/METHODS: Single-dose, multicenter, placebo-controlled study. Adults with history of migraine for ≥1 year were randomized to either 22 mg AVP-825 (15 mg emitted dose) or matching placebo. Patients treated a migraine of moderate or severe intensity and recorded symptoms at scheduled times.
RESULTS: 223 patients (mean age 42; 85% female) received treatment (112 AVP-825; 111 placebo). Primary outcome: 68% of AVP-825 patients reported headache relief at 120 min vs. 45% placebo (p<.01). Headache relief curves diverged early, reaching statistical significance at 30 min (42% vs. 27%; p<.05). At 120 min, 37% of patients receiving AVP-825 reported complete relief vs. 17% placebo (p<.01), while 70% vs. 45% reported meaningful relief (p<.001). A total of 28% on AVP-825 vs 12% placebo maintained complete relief at 24 hours without rescue medication (p <.01). Nausea, phonophobia, and photophobia were uncommon, and reduced in both groups (ns). No systemic AEs were reported in more than one patient. One patient reported mild, transient paraesthesias, no patient reported chest pressure/tightness. Most common (>5%) AEs reported were product taste (22%), nasal discomfort (13%), and rhinitis (6%).
CONCLUSION: This study replicates previous findings that AVP-825 produces fast and sustained migraine relief compared with placebo. Treatment was well tolerated, with few systemic adverse effects.
Study supported by OptiNose AS Norway and presentation supported by Avanir Pharmaceuticals, Inc.
Category - Headache: Therapeutics
Thursday, May 1, 2014 4:35 PM
I9: INS Data Blitz: Emerging Concepts in Headache Therapy (1:00 PM-5:00 PM)