Monday, April 02, 2012

Migraine Inhaler Levadex: Delayed By FDA


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The migraine community has been following the development of proposed migraine treatment medication Levadex for years as MAP Pharma has moved through the testing and approval process. Unfortunately, the FDA dealt them a set back last week.



Levadex is an inhaler that delivers a dose of the classic migraine treatment medication DHE (dihydroergotamine). The FDA has questions about the manufacturing process used for parts of the inhaler device. Specifically, they want to know how the aerosol cans of the drug are filled.

In their public response, MAP Pharma executes emphasized the FDA concerns did not relate to the efficacy or safety of Levadex. Research released in 2010 demonstrated the product was effective at alleviating the main symptoms of a migraine attack: pain, sensitivity to sound and light and nausea.
This is good news for Map Pharma, but also for migraineurs, who are always looking for new options for managing their debilitating migraine attacks. There is one other option for patients to use DHE at home: Migranal nasal spray. Otherwise, patients who need access to DHE must visit a clinic or hospital to receive it by IV. Rarely, some doctors will prescribe it for IM (intramuscular) use.

Related Posts:
Inhaled DHE Levadex for Migraine Treatment
Inhaled DHE Levadex Effective at Treating Migraines

Sources:
MAP Confident in Levadex, Plans Swift Response to FDA
Map Says Rejected Migraine Drug Doesn't Have Safety Issue


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DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.