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MAP Pharmaceuticals' Analysis of Positive Phase 3 LEVADEX(TM) Data To Be Presented in Late-Breaking Session at 14th Congress of the International Headache Society
Date:9/10/2009

found that LEVADEX also was effective compared to placebo in treating migraine:

  • in patients with or without allodynia;
  • at any time during the migraine attack, regardless of how long patients had waited to treat a migraine;
  • that occurs in the early morning, also known as "morning migraine";
  • in severely disabled and non disabled patients, as defined by a HIT-6 score;
  • with severe as well as moderate intensity of baseline pain;
  • with severe intensity of pain, providing pain relief at 10 minutes; and
  • with and without nausea, vomiting and aura.

Additional LEVADEX data from the Phase 3 trial showed rapid and sustained efficacy in treating migraine with:

  • pain relief at 10 minutes (p=0.16) and time to pain relief at 30 minutes (p=0.03);
  • sustained pain relief from two to 24 hours in 44 percent of patients compared to 20 percent for placebo (p<0.0001);
  • sustained pain relief from two to 48 hours in 36 percent of patients compared to 17 percent for placebo (p<0.0001, unadjusted for multiplicity); and
  • sustained pain free from two to 24 hours in 23 percent of patients compared to 7 percent for placebo, and from two to 48 hours in 18 percent of patients compared to 6 percent for placebo (p<0.0001 for both timepoints, unadjusted for multiplicity).

There were no drug-related serious adverse events reported in the trial. LEVADEX was well tolerated, with the most common adverse event reported being medication aftertaste at six percent, with two percent of patients receiving placebo also reporting medication aftertaste. The next most common adverse event was nausea at five percent, compared with two percent for placebo. Symptoms or sensitivities typically associated with commonly used triptan migraine treatments, such as ch
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SOURCE MAP Pharmaceuticals, Inc.
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