Levadex – Rejected Again
Levadex, an inhaled version of dihydroergotamine mesylate (DHE), has been rejected again by the FDA in the United States due to manufacturing concerns.
Levadex was recently at the centre of a deal worth almost a billion, when Allergan bought MAP Pharmaceuticals, the developers of the drug. Just over a year ago, with MAP at the helm, Levadex was not approved by the FDA due to concerns about the inhaler.
Allergan is probably best known for manufacturing Botox, also used for migraine treatment.
DHE is an old migraine treatment, but many still find it helpful. Often given in a hospital intravenously, many patients hope that an inhaled version will be a help at home.
Patients with chronic daily headache may also benefit from Levadex, assuming it gets to the market.
And it probably will. Allergan is hoping to apply for approval again before the end of the year.
17 April 2013 @ 6:32 pm
DHE given via an IV worked well for me when I was inpatient as part of treatment from MHNI in Ann Arbor. When I was discharged they put me on Methergine (an ergot and form of DHE) as a preventative. It worked well. The only reason I went off of it was the testing they made me have every 6 months to make sure I wasn’t forming fybroids (sp?) and I had started Botox which is really helping.
18 April 2013 @ 2:40 am
What is the difference between levadex and migranol?