Press Release

Printer Friendly Version View printer-friendly version
<< Back
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:

Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and FDA approval of our product candidates, resulting in, among other things, our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2003 under "Management's Discussion and Analysis of Financial Condition and Results of Operations." We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

Matt Czajkowski
Chief Financial Officer
Lisa Barthelemy
Director, Investor Relations

Replication or redistribution of EDGAR Online, Inc. content is expressly prohibited without the prior written consent of EDGAR Online, Inc. EDGAR Online, Inc. shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.