|POZEN's First Pivotal Study for MT 300 Hits Primary Endpoint; NDA On Track for Q4 Submission|
CHAPEL HILL, N.C., Jul 22, 2002 (BUSINESS WIRE) -- POZEN Inc. (Nasdaq: POZN), a pharmaceutical development company with a portfolio of product candidates for the treatment of migraine, announced the preliminary results from study MT 300-301, its first Phase III clinical study for MT 300.
The product candidate is designed to provide long-lasting pain relief for patients needing a convenient injectable therapy for severe migraine attacks with a reduced side-effect profile compared to existing injectable products. MT 300 is being developed as a new, improved formulation of dihydroergotamine (DHE) in a convenient pre-filled syringe that is suitable for at-home use. Injectable migraine products represented more than $200 million in 2001 U.S. sales.
MT 300-301 was a double-blind placebo-controlled study conducted in 619 patients with acute migraine across 36 centers in the United States. The study compared the efficacy of MT 300 to placebo, with sustained pain response as the primary endpoint and nausea and sensitivity to light and sound as secondary endpoints. Sustained response was defined as patients achieving pain relief within 2 hours of dosing and neither relapsing nor using rescue medicine over the next 22 hours.
Preliminary analysis of the data indicated that the sustained response rate for MT 300 was statistically superior to that for placebo, 37% versus 19% (p less than 0.001). Furthermore, MT 300 provided pain relief in significantly more patients at 2 and 4 hours compared to placebo (51% vs. 38% and 67% vs. 46% respectively, both p less than 0.001). Regarding secondary endpoints, MT 300 provided statistically significant relief from photophobia by 2 hours, relief from phonophobia by 3 hours and, in subjects with nausea at baseline, MT 300 provided statistically significant relief from nausea by 4 hours. Relief for secondary symptoms remained superior to placebo at 24 hours.
The most commonly reported adverse event was injection site reaction in 35% of the MT 300 subjects and 21% of the placebo subjects. Other adverse events occurring in at least 5% of patients include dizziness (6% vs. 2%, MT 300 vs. placebo), diarrhea (5% vs. 3%), nausea (5% vs. 2%), abdominal pain (5% vs. 1%), and limb pain (5% vs. 1%).
The second Phase III trial for MT 300 is nearing completion and submission of the NDA for MT 300 remains on schedule for the end of 2002.
POZEN Inc. is a pharmaceutical development company committed to building a portfolio of products with significant commercial potential in select therapeutic areas. POZEN's initial focus is on developing products for migraine therapy, a global market expected to exceed $2.8 billion this year. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN".
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