|POZEN's MT 100 Provides Significant Pain Relief in Difficult-to-Treat Migraine Patients|
CHAPEL HILL, N.C., Aug 22, 2002 (BUSINESS WIRE) -- POZEN Inc. (Nasdaq: POZN) announced today preliminary results of a Phase IIIb trial of migraine patients with an intolerance to triptans or with cardiovascular risk factors that would warrant cautious use of triptans.
Results of the study indicated that MT 100 provided superior sustained pain relief and two-hour pain relief compared to placebo. MT 100 is an oral tablet designed for first-line migraine therapy.
The double-blind, randomized, placebo-controlled study enrolled 238 patients across 19 centers in the United States and was designed to examine the effects of MT 100 compared to placebo in migraine patients with an intolerance to triptans (47% of the study population) and/or with cardiovascular risk factors (88% of the study population). Also, 35% of the study population had reportedly used a narcotic for their migraine attacks before participating in the study, and two-thirds of those experienced adverse events that limited their normal activity following narcotic usage.
The preliminary analysis of the data indicated that MT 100 provided statistically superior sustained pain relief compared to placebo. Of the patients taking MT 100, 41% reported sustained pain relief versus 20% for placebo. Sustained pain relief was defined as patients achieving pain relief within two hours of dosing and neither relapsing nor using rescue medicine over the next 22 hours.
Additionally, MT 100 provided statistically superior two-hour pain relief compared to placebo. Of the patients taking MT 100, 54% reported two-hour pain relief versus 33% for placebo. Regarding secondary endpoints, MT 100 had a statistically significant lower incidence of nausea and sensitivity to sound within 3 hours of dosing, and a statistically significant lower incidence of sensitivity to light within 4 hours of dosing compared to placebo. As seen in previous studies, MT 100 was well tolerated with no serious adverse or cardiovascular events reported in the study.
"Although we believe MT 100 will be best suited as first-line therapy for patients needing prescription migraine medicine, these data indicate its usefulness in these two populations of difficult-to-treat patients," said John R. Plachetka, Pharm.D., chairman, president and chief executive officer of POZEN.
POZEN 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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