08/04/2011
FDA Accepts New Drug Application for Migraine Medication Levadex
Levadex, an orally inhaled Migraine drug for the acute treatment of Migraines in adults, has been accepted as an NDA (new drug application) by the FDA. MAP Pharmaceuticals is a developing biopharmaceutical company focused on finding and commercializing new therapies for many of neurology's patients unmet needs. On January 31, 2011, MAP Pharmaceuticals announed that with Allergan's (makers of Botox) financial help, they will jointly promote Levadex to U.S. specialists.
"We are very pleased with the FDA's acceptance of the filing of our LEVADEX NDA submission as it is a significant achievement in the development of LEVADEX," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "This takes us another step forward in our effort to provide the underserved migraine patient population with a potential new treatment option."
MAP's Levadex will be a new approach to treating acute Migraine attacks using an oral inhaler. In the clinical trials, the participants used the TEMPO® proprietary inhaler finding significant relief after two hours, with less photophobia (sensitivity to light) and phonophobia (sensitivity to sound) too. Levadex is composed of a new formulation of dihydroergotamine (DHE). DHE is used to abort a Migraine attack by injection or can be used intravenously in a clinicial setting.
Although Levadex will be another great option for Migraineurs without cardiovascular issues, the fact remains there are not enough treatments for us, and no way to diagnose Migraine.
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Resources
Press Release. "MAP Pharmaceuticals Announces FDA Acceptance for Filing of NDA for LEVADEX®". Mountain View, C.A. August 2, 2011
Press Release. "UPDATE: Allergan To Help Sell Map Pharma's Migraine Treatment". Dow Jones Newswires. January 31, 2011.
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© Nancy Harris Bonk, 2011.Last updated August 3, 2011.
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