* 792-patient trial involved inhaled drug Levadex
* No drug-related serious adverse events, company says
* Shares more than double
(Adds details from study, CEO comments, shares)
NEW YORK, - MAP Pharmaceuticals Inc (MAPP.O) said on Tuesday its experimental orally inhaled migraine drug reached all four goals of a late-stage clinical study, and its shares more than doubled.
The drug, Levadex, showed statistical significance at two hours compared to placebo at relieving symptoms of migraine: pain, nausea, and sensitivity to light and sound.
Levadex, formerly called MAP0004, also reached secondary measures of the 792-patient trial, including sustained pain relief for 48 hours.
The trial results are a major boost for MAP, a small pharmaceutical company whose shares tumbled some 75 percent in February on a failed study for its experimental pediatric asthma drug.
"It really was all we were hoping for," MAP Chief Executive Tim Nelson said in an interview regarding the Levadex data. "We think we really hit the requirements that the patients consistently articulate they want for this disorder."
More than 29.5 million Americans suffer from migraines, an extremely painful often throbbing type of headache, according to the National Headache Foundation.
Levadex is an inhaled version of dihydroergotamine, an older drug used intravenously to treat migraines. Levadex is formulated to be used in MAP's proprietary inhaler, which is similar to a standard asthma inhaler except that patients breathe in to receive the drug rather than push on the device.
At two hours, 58.7 percent of patients on Levadex showed improved pain relief compared with 34.5 percent of patients on placebo.
Of the Levadex patients, 67.1 percent were nausea-free compared to 58.7 percent on a placebo. Some analysts had been concerned the product would fail to reach the nausea goal in the study. [ID:nBNG432342]
The company said there were no drug-related serious adverse events in the study.
At the request of the U.S. Food and Drug Administration, Mountain View, California-based MAP will conduct a second trial to confirm the results.
Nelson said the company was still designing the second trial but that he expects it will not be as large as the first.
The company will consider a partnership with a larger pharmaceutical company to help market Levadex beyond pain specialists, Nelson said.
"If we could find the right partner for this product, we think that could help to bring this product to many, many more patients than we might be able to do ourselves," Nelson said.
MAP shares rose to $6.75 in premarket trading, up from their Friday close of $3.15 on Nasdaq. The shares traded at $11 in February, before the asthma drug setback.
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