Levadex

13 February 2015

Whatever Happened to Levadex?

We’ve been talking about the new migraine drug, Levadex, since 2010. But it’s still not on the market. Will it ever be?

Levadex was still in the news last year, but under a brand new name. Semprana is the new name for Levadex, a new formulation of dihydroergotamine mesylate (DHE). It’s now owned by Allergan, the makers of Botox.

Semprana is an inhaled migraine abortive. It looks especially promising for nausea, and sensitivity to light and sound.

But last summer, Semprana was rejected yet again by the FDA in the United States. That’s the third time. The good news is that the rejection had nothing to do with whether or not Semprana works, or whether or not it’s safe. Instead, the FDA had technical concerns about the manufacturing and functioning of the device.

Semprana remains in Allergan’s pipeline, and is still looking like it could be a big player in the migraine market. But consumers probably won’t be seeing it in the local pharmacy until 2017.

17 April 2013

Levadex – Rejected Again

James Medications, News 2

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.

via: F.D.A. Rejects New Drug for Migraines

19 January 2010

Levadex – inhaled migraine drug on the way

James Medications, News 5

Levadex is something new, and it isn’t. It’s a new formulation of dihydroergotamine mesylate (DHE), known by many as DHE 45 (an injection) or Migranal (a nasal spray where the drug is accompanied by caffiene). DHE was introduced in the 40s, so it’s been around in various versions for a long time.

This new version known as Levadex is an inhaled version, brought to you by MAP Pharmaceuticals. Levadex will use the Tempo inhaler, designed especially for asthma and migraine patients.

In the United States, Levadex took a big step forward when the FDA decided not to ask for another phase III study. MAP Pharmaceuticals will go right ahead with their study of long term safety.

This part of the study is expected to be completed this year (2010).

So far Levadex looks promising for some patients, dealing not only with pain but other common symptoms – nausea, and sensitivity to light and sound. It’s believed that in a few years Levadex will be a major player in the migraine market. Then again, our understanding of migraine is changing and increasing at such a rapid rate, it’s hard to say what will be going on in a few years.

via FDA Clears the Way for MAP Pharmaceuticals