Experimental Migraine Drug Reaches Study Goals, Drug Maker Says

An experimental inhaled migraine drug has hit all four goals in a late-stage clinical study, said drug maker MAP Pharmaceuticals Inc.

The drug, Levadex, showed significant improvement in relieving symptoms such as pain, nausea, and light and sound sensitivity compared to placebo treatments, officials said. The drug, previously called MAP0004, achieved pain relief in 30 minutes and sustained relief for 48 hours, according to results of the 792-pateint clinical trial.

The trial results were a big boost for MAP, still stinging from a February 2009 failure of an experimental drug for pediatric asthma.

“It really was all we were hoping for,” MAP Chief Executive Tim Nelson said in a Reuters interview. “We think we really hit the requirements that the patients consistently articulate they want for this disorder.”

Migraine headaches cause debilitating and painful throbbing pain. As many as 29.5 million Americans suffer from migraines.

Inhaled Version of Older Drug

Levadex is an inhaled version of the older drug dihydroergotamine, which is used intravenously to treat migraines. Levadex is delivered by MAP’s inhaler, which is similar to a standard asthma inhaler except that rather than pushing on the device to deliver the drug, patients breathe in.

In the study, when measured at two hours, 58.7 percent of patients on Levadex showed improved pain relief compared with 34.5 percent of patients on placebo, officials said.

Just over 67 percent of people treated with Levadex were nausea-free compared to 58.7 percent on a placebo. Also encouraging was the finding that there were no drug-related serious adverse events in the study.

Another, smaller trial of Levadex will now begin to test the findings from the just-finished clinical study, officials said. If approved by the Food and Drug Administration, Levadex would compete with the popular triptan migraine drugs Imitrex and Zomig.

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