MAP says FDA does not need a new study of effectiveness of its migraine candidate Levadex

MAP Pharma says FDA doesn’t need new Levadex study

MOUNTAIN VIEW, Calif. — Regulators will not require MAP Pharmaceuticals Inc. to run a new effectiveness study on its migraine drug candidate Levadex, the company said Monday.

MAP Pharmaceuticals shares surged on the news, which may bode well for Levadex’s chances of winning regulatory approval and should also save time and money for the company.

The stock jumped $2.77, or 29 percent, to $12.36 after trading as high as $13.30 earlier.

Levadex is an orally inhaled drug intended to treat pain and other migraine symptoms.

MAP said it had planned to start another trial in the first quarter. The company said it was informed by the Food and Drug Administration that another effectiveness study would not be necessary. MAP reported successful late-stage trial results in May, but the FDA often requires drugmakers to prove the effectiveness of their products in multiple studies.

MAP is still running other studies of Levadex, including a trial intended to establish its safety. It said treatment in those studies will be complete in 2010.