Phase III data on OptiNose Bi-Directional System for Headache published-Avanir Pharma

Avanir Pharmaceuticals has announced the publication of results from TARGET, a pivotal Phase III study evaluating the efficacy and safety of OptiNose Bi-Directional System (sumatriptan drug delivery system) for Headache, in the January 2015 issue of Headache. The TARGET study data demonstrated relief of moderate or severe migraine headache as quickly as 15 minutes (19.4% sumatriptan vs. 14.4% placebo device) in subjects receiving sumatriptan). A significantly greater proportion of sumatriptan patients reported headache relief at 30 minutes (41.7% vs. 26.9%) and at every time point up to two hours post-dose compared with those using the placebo device (67.6% vs. 45.2%).

Relief was sustained through 24 and 48 hours in a greater proportion of patients who received sumatriptan vs. placebo. The treatment was well tolerated with a low incidence of adverse events (AEs), with the most common AEs being product taste (22%), nasal discomfort (13%), and rhinitis (3%); local AEs were transient and almost exclusively mild to moderate in severity. See: "A Randomized, Double-Blind, Placebo-Controlled Study of Breath Powered Nasal Delivery of Sumatriptan Powder (AVP-825) in the Treatment of Acute Migraine (The TARGET Study)" Roger K. Cady et al. Headache, 30 OCT 2014 DOI: 10.1111/head.12472