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The FDA Rejects the Application for Levadex

Last month the U.S. Food and Drug Administration (FDA) rejected Levadex ®, an inhaled form of the migraine medication, dihydroergotamine (DHE). This is the second time the agency has failed to approve the medication.

DHE has been used in migraine treatment for many years, but it 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. The inhaled form of the medication is meant to work quickly and can be used at home.

In March, 2012, when the FDA first rejected the drug, it cited concerns about the medication’s chemistry, manufacturing and controls. This time the FDA again raised concerns about the drug’s manufacturing, in particular about the company contracted to fill the drug canisters. In a recent press release, Allergan said it believes it will be able to address those concerns fully because it has now purchased the company in question and has assumed  running it.

Allergan recently spent nearly $1 billion dollars to purchase MAP Pharmaceuticals, the company that developed Levadex. Allergan officials said they will continue to work toward making the medication available. They believe the FDA will take action again before the end of the year.

“The company is committed to bringing Levadex® to market as a potential new acute treatment to address a significant unmet need among the millions of people living with debilitating migraines,” a company press release indicated.

NHF’s Executive Chairman and founder, Seymour Diamond, MD, noted his support for this potential new medication.

“In my almost 50 years of practicing headache medicine, I have used dihydroergotamine successfully in many patients. It is still prescribed at many headache centers, including the Diamond Headache Clinic in Chicago. My hopes are that these manufacturing problems can soon be resolved so that the clinician treating migraine will be able to use another effective agent,” Dr. Diamond said.

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