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Positive results for migraine drug

MAP Pharmaceuticals is to prepare a New Drug Application for novel migraine drug Levadex after it showed positive results in safety trials

MAP Pharmaceuticals is to prepare a US Food and Drug Administration (FDA) New Drug Application (NDA) for novel migraine drug Levadex (dihydroergotamine) after it showed positive results in safety trials.

MAP reported that all non-asthmatic patients and a subset of asthmatic patients had completed 12 months of treatment in an open-label trial testing the drug's safety. Levadex was seen as well-tolerated with no serious adverse events reported.

Levadex is an orally inhaled migraine therapy to be administered by patients themselves using an inhaler.

Patient treatment had also been assessed in a further trial assessing a participant's QT interval – a measure of the heart's electrical cycle. A prolonged QT interval can be a risk factor in certain heart related conditions.

The results of the QT trial will be released in the fourth quarter of 2010 according to MAP.

In a separate statement, MAP reported the results of a further trial comparing the effects of the drug on pulmonary artery pressure compared dihydroergotamine mesylate (DHE) administered intravenously (IV), as well as placebo. No significant difference between the Lavedex and placebo groups was recorded, although the IV DHE group showed an increase in pulmonary artery pressure.

Pulmonary artery pressure can have several negative effects including shortness of breath, dizziness and fainting.

MAP has said it plans to submit the NDA for Levadex in the first half of 2011.

9th September 2010

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