Inhalable Migraine Drug Levadex Headed for FDA Approval


For the estimated 28 million people in the United States who suffer with migraine, a new inhalable migraine drug that is headed for FDA (Food and Drug Administration) approval later this summer could be a welcome addition to the treatment arsenal. Levadex™ was developed by MAP Pharmaceuticals.

The new inhalable drug Levadex is for acute migraine treatment

MAP Pharmaceuticals anticipates submitting its New Drug Application for the new inhalable migraine drug with the FDA during the first half of 2011. The company is collaborating with Allergan, Inc., and the two plan to co-promote Levadex to pain specialists and neurologists in the United States. Allergan is the maker of Botox® (onabotulinumtoxinA), a medication for chronic migraine.

Levadex is an orally inhaled therapy that patients can self-administer for acute migraine. It contains a proprietary formulation of dihydroergotamine (DHE), which is already available via a nasal spray, IV, and injection, and it involves a proprietary delivery system called the TEMPO inhaler from MAP Pharmaceuticals.


According to information released by Allergan, results of the Levadex Phase III trial revealed that patients who took the drug had statistically significant improvement two hours after treatment when compared with patients who took a placebo. Improvement was significant in pain relief (58.7% of treated patients vs 34.5% of placebo), free of hypersensitivity to sound (52.9% vs 33.8%), free of hypersensitivity to light (46.6% vs. 27.2%), and nausea free (67.1% vs. 58.7%).

The most common side effects reported with medication use was an aftertaste in 6 percent of patients, followed by nausea in 5 percent. No decrease in lung function was observed in either group of patients.

If the new inhalable migraine drug gets FDA approval, it will join other abortive drugs (taken to stop migraine when it is starting or has already started). Among them are the triptans, which include sumatriptan (Imitrex), zolmitriptan (Zomig), and naratriptan (Amerge), as well as dihydroergotamine (Migranal Nasal Spray) and ergotamine tartrate (Cafergot).

Allergan Inc.
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I need migraine relief.
Levadex was not approved by the FDA as of April 2013 because of problems with the inhaler. The company reportedly immediately took steps to remedy the situation but as of this date approval has not been granted.