Early Results of New Migraine Formulation Look Promising

Levadex, a new formulation of dihydroergotamine which is given as an oral inhalation, has been shown in a phase III clinical trial to provide quick and sustained pain relief for migraine attacks. Dihydroergotamine (DHE) is in a class of medications called ergot alkaloids. It works by tightening blood vessels in the brain and by stopping the release of natural substances in the brain that cause swelling. While this formulation is new, DHE is not a new drug and is currently available in other dosage forms including as an injection for hospital administration as well as a nasal spray. DHE is also available in injectable form that patients can inject subcutaneously at home, D.H.E. 45.

MAP pharmaceuticals has been testing the new inhaled formulation of the drug for eventual introduction into the market as a new alternative for patients in need of rapid and prolonged relief of headache pain and other migraine symptoms.

In the phase III trial, 395 patients received Levadex while an approximately equal number of people received a placebo, a formulation containing no active drug. Two hours after taking the drug, people who received the Levadex had a significant improvement compared to people who took the placebo in all four main areas that were studied in the trial including:

  • Pain relief: 58.7% of patients who received Levadex as compared with 34.5% for placebo
  • Phonophobia free: 52.9% of patients who received Levadex compared with 33.8% for placebo
  • Photophobia free: 46.6% of patients who received Levadex compared with 27.2% for placebo
  • Nausea free: 67.1% of patients who received Levadex compared with 58.7% for placebo

The most common side effect reported in the phase III trial was medication aftertaste, 6% versus 2% for placebo. The next most common adverse event was nausea, with 5% of the people taking Levadex having nausea versus 2% for individuals taking a placebo. Because this drug is given by inhalation, lung function was also evaluated and there were no negative lung side effects reported.

While still investigational, the company has completed its clinical testing and plans to submit a New Drug Application (NDA) to the FDA in the first half of 2011. Recently, the company also announced that it would co-market its drug to neurologists and pain specialists with Allergan, the company that makes Botox for migraine. Botox, in contrast to Levadex which was studied for symptomatic relief of acute migraine, is FDA approved to treat headaches in adults with chronic migraine (15 or more days with headaches lasting four hours a day or longer) in people 18 years or older. By marketing these products together, the companies hope to be able to address a broader spectrum of migraine sufferers.

Click here to learn more about the drug approval process for prescription medications.

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