|Results from POZEN Phase IIIb Study Show Early Treatment with MT 100 Improves Efficacy; The Rate of Sustained Pain Relief for Migraine Patients in Study Nears 50%|
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Sept. 24, 2003--POZEN Inc. (NASDAQ: POZN), a pharmaceutical company developing therapeutic advancements in a cost effective manner, announced today the results of a Phase IIIb study demonstrating that MT 100(TM) provides superior sustained pain relief over placebo for patients in the early treatment of migraine. Sustained pain relief is defined as patients achieving pain relief within two hours of dosing and neither relapsing nor using rescue medicine over the next 22 hours. MT 100 is being developed as an oral first-line therapy for the treatment of migraine.
The Phase IIIb randomized, double-blind, placebo-controlled study included 332 patients from 20 sites across the United States. The study evaluated the efficacy of a single tablet dose of MT 100 when given within one hour of migraine pain onset as compared to placebo. The data demonstrated that MT 100 provided sustained pain relief in statistically significantly more patients with moderate and severe baseline pain than placebo, 47% vs. 28% (p less than 0.001), respectively. In those patients who took MT 100 when their pain was of moderate intensity, the difference between MT 100-treated and placebo-treated patients who achieved sustained pain relief was even greater, 54% vs. 31% (p less than 0.001), respectively.
"Unlike drugs that may provide relief at two hours, which then dissipate over time, these data provide compelling evidence that MT 100 provides 24-hour relief with a single tablet for many migraine sufferers. The data also show that early treatment with MT 100 increases the likelihood of pain relief than when patients treat later," stated John R. Plachetka, Pharm.D., chairman, president and chief executive officer of POZEN.
Additionally, MT 100 provided statistically superior two-hour pain relief in patients with moderate and severe pain compared to placebo, 52% vs. 39% (p=0.035). MT 100 also provided statistically significant relief of the associated symptoms of migraine including sustained relief from nausea, sensitivity to light, and sensitivity to sound.
The company announced on July 31, 2003 that it submitted a New Drug Application to the Food and Drug Administration for the marketing approval of MT 100. In addition, POZEN announced on October 8, 2002, that it submitted a Marketing Authorization Application for MT 100 to the Medicines Control Agency in the United Kingdom. If approved in the U.K., POZEN will seek approval in selected European countries through the European Union Mutual Recognition Procedure.
POZEN is a pharmaceutical company developing therapeutic advancements in a cost effective manner. Product development efforts are focused on diseases with unmet medical needs where POZEN can improve efficacy, safety, and/or patient convenience. Since its inception, POZEN has developed the largest and most advanced product pipeline in the field of migraine. POZEN has development and commercial alliances with GlaxoSmithKline, Xcel, and Nycomed. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: www.pozen.com.
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