Intranasal sumatriptan powder: Additional Phase III data

Additional data from the double-blind Phase III TARGET trial in 230 patients with acute migraine pain showed that 22 mg intranasal AVP-825 led to headache relief at 2 hours post-dose, the primary endpoint, in 67.6% of patients vs. 45.2% for placebo (p=0.002). Additionally, 41.7% of patients receiving AVP-825 reported headache relief at 30 minutes post-dose vs. 26.9% for placebo (p=0.03), with headache relief sustained at 24 hours (44% vs. 24%, p=0.002) and 48 hours (34% vs. 20%, p=0.01). Furthermore, a significantly greater proportion of patients receiving AVP-825 were pain-free at 2 hours post-dose (34% vs. 17%, p=0.008) and experienced meaningful pain relief of migraine within 2 hours of treatment (70% vs. 45%, p<0.001) vs. placebo and significantly fewer patients receiving AVP-825 required rescue medication vs. placebo (37% vs. 52%, p=0.02). Data will be published in Headache. Avanir previously reported that AVP-825 met the primary endpoint vs. placebo (see BioCentury, Dec. 17, 2012). ...