Attendees at the AAN 2015 conference got a look at a novel drug-device for acute migraine treatment. AVP-825 is a breath-powered intranasal delivery system of lower-dose powdered sumatriptan. This drug-device combination is designed as a potential non-oral treatment option with the goal of faster and more effective systemic absorption and pain relief without the need for injection.
A meta-analysis of the pooled results of phase 2 and phase 3 clinical trials of AVP-825 was presented, which demonstrated efficacy in a cohort of patients with episodic migraine without either sumatriptan or 2 or more triptan failures and with normal palate and nasal function. Beginning at 30 minutes, significant pain relief occurred compared with placebo (44.8% vs 27.9%). Pain freedom at 2 hours was noted in 40% compared with 19.21% in the placebo group. 46.9% of treated patients reported no clinical disability at 2 hours vs 27.9% in the placebo group (P<.01). No significant adverse events were noted: 1 patient reported paresthesias; 20% noted abnormal taste; and 11% reported mild nasal discomfort.
Overall this meta-analysis is consistent with the prior phase 2 and 3 clinical trials, which demonstrated efficacy of AVP-825 as a non-oral acute migraine treatment option.1
This poster session comes as a precursor to the presentation of data from the COMPASS study (Breath Powered™ Nasal Delivery of 22 mg Sumatriptan Powder (AVP-825) Versus 100-mg Oral Sumatriptan in Acute Migraine: A Comparative Clinical Trial).2 This is a recently completed multicenter, double-dummy, crossover, 12-week study that compares AVP-825, 100-mg oral sumatriptan, and placebo for acute migraine treatment. COMPASS demonstrated that for 2 or more attacks, AVP-825 was superior to oral sumatriptan at 30 minutes pain relief (37.6% vs 18.8%, P<.0001) and 30 minutes pain freedom (15.7% vs 6.4%, P=.015).
Overall, this study suggests that AVP-825 may not only be a promising non-oral triptan acute treatment, but may be more efficacious than its oral counterpart.
1. 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: AAN 2015 Washington DC.
2. Lipton R, et al. Presentation S23.003. Consistency of response in the COMPASS Study [Breath Powered™ Nasal Delivery of 22 mg Sumatriptan Powder (AVP-825) versus 100 mg oral sumatriptan in acute migraine: a comparative clinical trial]. Presented at: AAN 2015 Washington DC.