A migraine drug from MAP Pharmaceuticals(MAPP Quote) provided significant relief from headache pain and other symptoms, according to results from a phase III study released Tuesday.
The Mountain View, Calif.-based drugmaker is developing the migraine drug, known as Levadex, on its own, although MAP is expected to seek out a larger drug company as a partner based on the positive results from this first of two planned phase III studies. Levadex is an inhaled form of dihydroergotamine (DHE), a drug used intravenously to treat migraines. Migraine sufferers breathe Levadex into their lungs using MAP's proprietary inhaler. MAP said according to the results of the phase III study 59% of migraine sufferers treated with Levadex were pain free after two hours compared with 35% patients treated with a placebo. The result was statistically significant. Levadex also demonstrated a statistically significant improvement over placebo for sensitivity to light and sound as well as nausea reduction. Pain relief set in over 30 minutes and continued for up to two days. The phase III study enrolled 792 migraine headache patients, with 46% of patients reporting severe pain and 54% reporting moderate pain prior to treatment. Levadex was well tolerated, with 6% of patients reporting medication after taste as the most common adverse event, according to MAP. "We are very pleased with these results and look forward to continuing development of Levadex with the goal of bringing this differentiated therapy to the many patients who suffer from the debilitating effects of migraine," said Timothy Nelson, MAP's CEO, in a statement.- Loading Comments...
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