MOUNTAIN VIEW, Calif. (AP) — Regulators will not require MAP Pharmaceuticals Inc. to run a new effectiveness study on its migraine drug candidate Levadex, the company said Monday.
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.
Levadex is an orally inhaled drug intended to treat pain and other migraine symptoms.
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 $3.11, or 32 percent, to $12.70.