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MT 100 Provides Sustained Relief Over Placebo in Phase III Migraine Study
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.
Source: POZEN Inc.