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

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Hamell

Hamell is a full-service agency with a clear focus on delivering evidence-based, sustained behaviour change. So, whether you are looking...

Latest intelligence

50 questions for delivering an exceptional healthcare brand experience
Our 50-question brand planning checklist for healthcare ensures you deliver an exceptional experience, based on what your stakeholders want and need...
The brand strategy revolution
Introducing a new tool for developing a stakeholder-centric brand, based on the experience your patients and their HCPs want and need....
How Medisafe is using AI to improve patient adherence
Dina Patel speaks to Omri Shor, Co-Founder and CEO of Medisafe, to find out how his medication management app is tackling the problem of poor adherence....

Infographics