Levadex: Updated Information on New Migraine Formulation

Levadex, a new formulation of dihydroergotamine which is given as an oral inhalation, has been shown in a phase III clinical trials 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. MAP pharmaceuticals has been testing the new 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 one of the original Phase 3 trials, patients taking Levadex had statistically significant improvement at two hours compared to patients on placebo for all four major migraine goals:

  • Pain relief: 58.7 percent of patients who received LEVADEX compared with 34.5 percent for placebo
  • Phonophobia free: 52.9 percent of patients who received LEVADEX compared with 33.8 percent for placebo
  • Photophobia free: 46.6 percent of patients who received LEVADEX compared with 27.2 percent for placebo); and
  • Nausea free: 67.1 percent of patients who received LEVADEX compared with 58.7 percent for placebo.

Recently, the company announced that it would be presenting some additional data from 2 recently conducted safety studies. The first was an open-label study that compared the characteristics of the drug and how well it was tolerated in a group of smoking vs. non-smoking volunteers. Results concluded that there was little difference in how quickly or how well the drug was absorbed, how long it stayed in the body or how well it was tolerated among both groups. A second, separate safety study looked at a comparison between the orally inhaled form of DHE and the drug given intravenously and found little difference in the effect on heart functions however adverse events were more frequent in those who received the intravenous formulation.

Common adverse effects seen with the orally inhaled formulation include a medication aftertaste as well as nausea. Both of these adverse events are relatively infrequent. While the drug is given via inhalation, lung function has not been shown to be negatively affected.

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