FDA Declines to Approve Levadex

The United States Food and Drug Administration (FDA) declined last month to approve the migraine drug, Levadex ®, an inhaled form of dihydroergotamine (DHE). Approval of the medication is still possible once MAP Pharmaceuticals, the drug’s manufacturer, addresses FDA concerns. The company plans to proceed and will meet with FDA officials later this year to address their concerns.

DHE has been used for decades to treat migraine, but it works best when given intravenously or via injection, requiring a hospital or clinic visit. A DHE nasal spray also exists but its action is slow. For years, researchers have been seeking effective, fast-acting methods of administering the drug.

MAP Pharmaceuticals recently stated in a press release that the FDA did not raise issues related to the drug’s safety or efficacy in its Complete Response Letter. Rather, FDA concerns related to an inspection of a third-party manufacturing plant and the drug’s chemistry, manufacturing and controls.

“MAP is committed to making this important new therapy available to people who experience migraine. We will continue to work closely with the FDA to finalize our product labeling and to address the issues raised in the Complete Response Letter as quickly as possible,” said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals.


Source: http://www.headaches.org/2012/04/15/fda-declines-to-approve-levadex/

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