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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Comments

View Comments (12)
  • Katja Nemethi
    8 years ago

    how long does it stay in the blood and does it also helps with hormone related migraine? Because in my case the Imigran only stays about 24 hrs.

  • April Kenney
    8 years ago

    I have been in pain, nauseous in the dark for the past 3 days. Maxalt didn’t touch the pain! I would welcome the clinical study with an IV of DHE right now. This does sound hopeful.

  • Nancy Brown Albert
    8 years ago

    omg you poor girl……….cant believe you are still hurting………

  • Jenn Raymond
    8 years ago

    Oh no April, I hope you feel better soon! I am thinking of you!

  • Bonnie Leigh Keegan
    8 years ago

    Praying for you April….sure wish this healing would kick in.

  • Christina Rasmussen
    8 years ago

    I have only had DHE in the ER whwn I ru out of my Imitrex and or the Imitrex hasn’t worked(24 hrs. free of imitrex before they can give you an IV of DHE) I loved the IV…no side effects, hopefully this new study goes well. I have had much success with Imitrex lately, but only the injection, the pills don’t touch the pain or nauseousness. Good luck!

  • Diane Riedel
    8 years ago

    I currently use DHE injected sq when I have a aura migraine. It quickly eliminates the aura and photophobia. The residual head pain is also lessened. This is the best drug I have ever used for migraines, and I have tried them all. I can only take this 3x per week, so I always hope I have no more than 3! Complicating all of this I have chronic daily headache/transformed migraine. I have head/ neck pain 24/7. I hope this info helps someone!

  • Trish Tawney Otto
    8 years ago

    This sounds promising! I get tried of taking Treximet.

  • Tonia Mcintosh
    8 years ago

    wow, treximet doesnt work for you? they gave me imitrex, pill form and it did nothing, I was on fiorcet for a long time, it worked for a long time, then all of a sudden it didnt work anymore. then i tried treximet, and it worked, i just got a new script for it, but its real funny now when i get a headache the fiorcet is working again. I have no idea what that is about. But i do tell you when i went through a six week bout, thaats when my fiorcet stopped workking. the only thing that gave me relief was the treximet. But i truly hope you find something that works for you.

  • Liz Halsell Martin
    8 years ago

    How do you get in on one of these clinical trials? We are desparate to help my daughter.

  • Kevin Jackson
    8 years ago
  • Kevin Jackson
    8 years ago

    Go to the website of this company and see if they provide any information: MAP pharmaceuticals, this company makes the drug. They maybe through with clinical trials since it was a phase 3 trial! Good Luck!!

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