WASHINGTON — Low-dose sumatriptan powder delivered nasally via the AVP-825 Breath Powered system produces rapid and sustained relief of headache and is well-tolerated, results of pooled analyses indicate.
Roger Cady, MD, of Headache Care Center in Springfield, MO, and colleagues confirmed findings from individual trials for safety and efficacy of AVP-825 that indicated the treatment was well tolerated with mild and transient adverse effects.
The analyses, presented in a poster session at the American Academy of Neurology 2015 Annual Meeting, brought together data from phase 2 and phase 3 placebo-controlled trials of AVP-825, the Breath Powered Bi-directional device that contains 22mg of sumatriptan powder. The device delivers the drug broadly onto the mucosa beyond the nasal valve for superior absorption.
The analyses included data from 143 participants who used AVP-825 and 136 participants who were given placebo. Participants had an active history of migraine with a Headache Severity score of grade 2 or 3 for at least one year and no history of resistance to sumatriptan. The phase 2 trial examined the efficacy and safety of AVP-825 22mg or 11mg vs. placebo, and the phase 3 trial evaluated the efficacy and safety of AVP-825 vs. placebo.
At all time points from 30 to 120 minutes post-dose, patients using AVP-825 experienced greater pain relief than those taking placebo. At 30 minutes, 44.8% of those who used AVP-825 experienced pain relief compared to 27.9% of the placebo group. At 120 minutes post-dose, 70.6% of AVP-825 users had pain relief compared to 44.9% of the placebo group. Pain freedom was experienced by 39.9% of the AVP-825 group at 120 minutes post-dose compared to 19.1% of the placebo group.
At 120 minutes post-dose, 46.9% of AVP-825 patients reported no clinical disability compared to 27.9% of the placebo group, a statistically significant difference (P<.01), and 53.9% of AVP-825 patients reported no migraine symptoms, including photophobia, phonophobia, nausea, and vomiting, compared to 39.7% of the placebo group (P<.05).
Headache relief was sustained through 48 hours after dosing with AVP-825, and the group was also less likely to use rescue medication during that time period (35.7% vs. 54.4%). Pain relief occurring within the 120-minute endpoint occurred in over 70% of AVP-825 patients vs. 44.9% of the placebo group. These results were consistent with phase 2 and phase 3 data, which saw AVP-825 patients reach meaningful pain relief within a median of 50 minutes and 48 minutes, respectively, whereas those in the placebo group did not achieve meaningful pain relief within the 120-minute endpoint.
“I believe effective parenteral therapy is a cornerstone of acute treatment of migraine,” Cady told Neurology Advisor. “Once approved, AVP-825 will deliver that effectiveness to patients and be a welcomed addition to the treatment ‘tool box’ of many migraineurs.”
Among the pooled populations for safety analyses (AVP-825=151; placebo=150), no deaths or serious treatment-emergent adverse events (TEAEs) occurred, including chest pain or pressure. One patient reported mild paresthesia.
Thirty-six percent of the AVP-825 group reported TEAEs vs. 11% of the placebo group. TEAEs, most described as mild in intensity, included abnormal taste (20%), nasal discomfort (11%), rhinorrhea (5%), and rhinitis (2%) for the AVP-825 group.
- Cady R et al. Abstract P1.315. Pooled Analyses of Randomized, Double-Blind, Placebo-Controlled Studies of A Breath Powered™ Nasal Delivery Device Containing 22 mg Sumatriptan Powder (AVP-825) in the Treatment of Episodic Migraine. Presented at: American Academy of Neurology Annual Meeting 2015; April 18-25, 2015; Washington, D.C.
Disclosure: This study was co-funded by Avanir Pharmaceuticals and OptiNose U.S.