Please login to the form below

Not currently logged in
Email:
Password:

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

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Havas Lynx Group

We are the Havas Lynx Group. Devoted to fresh thinking. Changing the way the world does healthcare communications for the...

Latest intelligence

Women in science
The role of women in science and technology
Why the lack of female leaders in pharma and life sciences is a problem that still needs to be fixed...
Maria Dahl
China’s homecoming heroes fuel a biotech boom with rapid CAR-T advances
China secures a place at the forefront of innovative medicine...
Virtual Research Grants Submission and Approval Program
Impetus Digital summarizes how a client established an independent grant review committee and a virtual grant submission and approval program, without having to travel and meet in person....

Infographics