Data presented by Peter J. McAllister, MD, New England Institute for Neurology and Headache, Stamford, Connecticut, USA, indicate that, in addition to providing migraine relief, breath-powered nasal delivery of low-dose sumatriptan powder (AVP-825) is associated with significantly improved functioning and a reduction in disability.

AVP-825 is an investigational drug-device combination product containing sumatriptan powder (22 mg) delivered intranasally via breath-powered technology. Clinical trials of AVP-825 in the acute treatment of migraine have shown headache relief at levels comparable with the most effective triptans [Cady RK et al. Headache. 2015; Djupesland PG et al. Cephalalgia. 2010]. Dr McAllister presented secondary outcomes from a recent phase 3 study [Cady RK et al. Headache. 2015] showing that AVP-825 shortens the time to meaningful relief and lowers clinical disability scores compared with placebo.

TARGET [NCT01462812] was a phase 3, multicenter, parallel-group trial composed of men and women diagnosed with episodic migraine ≥ 1 year prior to screening who reported 1 to 8 migraines per month during the 12 months prior to prescreening, had verified airflow through both nostrils, had the ability to close the soft palate, and demonstrated ability to use the breath-powered device. Participants were randomized to AVP-825 (n = 108) or a placebo (n = 104). Migraine symptoms were recorded predose and at 10, 15, 30, 45, 60, 90, and 120 minutes postdose. The Headache Impact Test (HIT-6) and clinical disability scale scores were used to measure headache-associated burden and disability at baseline.

Participants (mean age 42 years; 83.5% women; 85.8% white) reported a mean of 4.5 headaches per month; most (83%) associated with moderate pain and without aura (81.1%). HIT-6 results showed substantial headache burden and associated disability, ie, approximately 39% of patients routinely experience impairment with work and 34% with daily activities; 50% always or very often experience severe pain; and 80% always or very often wish they could lie down. At baseline, 57% of patients randomized to AVP-825 and 55% of placebo patients had clinical disability scale scores indicating moderate or severe disability.

The median time to meaningful headache relief with AVP-825 was 47.5 minutes. Compared with the placebo group, significantly more patients using AVP-825 reported experiencing meaningful relief by 120 minutes (P = .0004). Clinical disability scale scores improved over time; by 45 minutes postdose, these scores were significantly reduced in the AVP-825 group (P = .0343).

Disability was significantly reduced at 120 minutes postdose in the AVP-825 group compared with the placebo group (P = .0430). Specifically, by the 120-minute end point, 19% of patients treated with AVP-825 and 35% of placebo-treated patients reported moderate or severe disability compared with 57% and 55%, respectively, at baseline (P < .05).