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Manufacturers of Levadex Pursue FDA Approval

MAP Pharmaceuticals recently announced plans to resubmit its new drug application to the United States Food and Drug Administration (FDA) for Levadex, an inhaled medication meant to treat acute migraine. Company officials recently met with representatives from the FDA and say they hope to resubmit the application in the third or fourth quarters of this year.

In March, the FDA sent a Complete Response Letter to the biopharmaceutical company, declining to approve the drug and citing concerns about the drug’s chemistry, manufacturing and controls. Now MAP Pharmaceuticals representatives say those issues have been resolved or will be dealt with as part of the resubmission of the application.

Levadex is an inhaled form of the common migraine drug, dihydroergotamine (DHE), which has been used to treat migraine for decades. DHE is most effective when given intravenously or via intramuscular injection, requiring a hospital or clinic visit. A DHE nasal spray is also available but is slow to take effect. For years, researchers have been seeking effective, fast-acting methods for taking the drug.

MAP Pharmaceuticals officials say they were encouraged by the meeting with the FDA and the “collaborative dialogue” that will help facilitate the process. “We believe Levadex has the potential to be an important new therapy for people who experience migraine and look forward to being able to provide it to patients whose needs are not being met by currently available treatments,” said Timothy S. Nelson, the company’s president and chief executive.

The FDA will determine the review timeline once it has accepted the resubmission.

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