MAP Pharma’s New Drug Application for Levadex Accepted for Review

The Food & Drug Administration (FDA) has accepted MAP Pharmaceuticals’ new drug application (NDA) petition for Levadex for review. Levadex is an inhaler-based delivery mechanism for an existing migraine treatment medication called DHE.

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DHE, which stands for dihydroergotamine, is a member of the ergot family of drugs. It is an older migraine treatment medication (introduced in 1945) than the more recently introduced triptan family of medications (Imitrex, Relpax, etc.). It is currently available to patients in nasal spray form (brand name Migranal) and on a more limited basis by intramuscular injection. Doctors can also give it by IV in the clinic or hospital setting. Levadex would offer a new delivery method for patients to be able to use DHE for treatment of acute migraine attacks at home. MAP Pharmaceuticals says patients using their inhaler experience fewer side effects than patients using other available forms of DHE, especially nausea and bad aftertaste, and get quick relief.

Levadex Migraine Inhaler

For a drug to become available to patients, the Food and Drug Administration (FDA), which is an agency of the federal government, must approve it and issue its manufacturer a license for a particular use. After completing the first three phases of the clinical trial process, the pharmaceutical company files a new drug application (NDA) to start the approval process.

The purpose of the NDA is to provide the FDA with sufficient information to determine if the drug is safe and effective, the adequacy of the package insert and whether the manufacturing standards will ensure safety and consistency. The information in the NDA tells the FDA what happened during the first three phases of clinical trials on animals and humans, how the drug affects the patient’s body, what side effects were found and what the medication contains. Within 60 days the FDA must decide whether to accept the petition for review or reject it for being incomplete.

Once the petition is accepted for review, the FDA’s team of physicians and scientists will review the data submitted by the MAP Pharmaceuticals in its NDA for Levadex. The FDA team will look for weaknesses in the manufacturer’s data and decide whether the conclusions the company made in its application are correct. Although this is understandably a labor and time intensive process, the FDA says its goal is to review and act on at least 90% of new drug application petitions within 10 months of the filing date.

If the FDA team decides the drug’s benefits outweigh its risks, they will approve it for use by patients for a particular purpose. If the FDA teams finds itself unable to make a decision on the available data, sometimes the FDA team will ask for additional information to help make the decision. A drug may end up going through a number of review cycles in order to address all of the concerns raised by the FDA team. If the company is ultimately unable to correct the problems that have kept the drug from being approved, the FDA will deny the NDA petition. If the pharmaceutical company later wants to have the drug approved for an additional purpose they will need to go through the approval process again for that use.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The Migraine.com team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.
View References
Clinical Trials.gov: Understanding Clinical Trials | MAP Pharmaceuticals: Inhaled Migraine Therapy | MAP Pharma Gets FDA Acceptance to File Levadex NDA | FDA: New Drug Application (NDA)

Comments

View Comments (22)
  • David Vilson
    7 years ago

    Inhalants are some of the most widely abused substances found in the market. These compounds have the ability of causing damage to many parts of the brain and other delicate body organs like the lungs & kidneys. Your heart would also be put in jeopardy since the toxic substances found in these compounds have the capacity to clog up arteries. In regards to problems pertaining to the brain this substance has the effect of triggering them in a minor level but such conditions would get bigger if help is not sought promptly.

    http://inhalantsabuse.com/

  • Teri Robert
    7 years ago

    Just what does this have to do with the post or Migraines?

  • Teresa Woodall Certain
    8 years ago

    I used DHE by IV in hospital because of migraine lasting for 6months non stop and it stopped my headaches. I’m on 4 medications now for migraines and they do not work, still have them everyday. Would welcome using a DHE inhaler to see if it would work. Sick of headaches constantly.

  • Carolyn Crawford Brewington
    8 years ago

    I am so sorry you have those. I too had them evey day and then was put on Depakote, which is a seizure drug. Thankfully I now can go for a long time without having a headache. Don’t give up, there has to be help for you somewhere.

  • Charry Black McDonald Jones
    8 years ago

    I’ve used Migranal in the past and like Imitrex I use now sometimes it works sometimes it doesn’t. I also take Topamax twice a day for prevention. One day maybe something will work completely.

  • Charry Black McDonald Jones
    8 years ago

    Yes it does take awhile for it to start working and it doesn’t completely stop the migraines but it does help some. Good luck to you!

  • Barb Moos
    8 years ago

    I have been taking topamax for over a week now for prevention and it hasn’t seemed to help yet.This 2nd week I am suppose to take 2 pills at bedtime,3rd week 3 pills at bedtime and 4th week 4 pills at bedtime.Does the topamax work for you and if it does how long did it take to work?I read that preventitive migraine meds could take up to 2 mos.

  • Sherri Capizzi
    8 years ago

    I am willing to try the inhalants, as I cant take the injectables, they bottom out my blood pressure, the pills do nothing, I’m on a topamax to slow down the episodes but I still get them , so when I do sometimes Imitrex works sometimes it don’t.

  • Krista Furgerson
    8 years ago

    Thank goodness for DHE. I’ve been using the DHE shots for about a year. The triptans don’t do jack for me and give me side effects. And my doc tells me I can take DHE more than 2-3x a week without worrying about rebounds.

  • Ellen Schnakenberg
    8 years ago

    Inhalation can be one of the best methods of delivery – so quickly effective and at the same time non-invasive. I am not a DHE compatible person, sadly, so I wish there were more meds utilizing this delivery system.

  • Louise M. Houle
    8 years ago

    The DHE shots work for me but NOT Migranal, the inhaler. Perhaps less gets absorbed into the system through the nose…

  • Ellen Schnakenberg
    8 years ago

    Crissy, I think it’s all in the article…

  • Susan Bug Bunton
    8 years ago

    I agree with u on the dhe I was on the shots sherri

  • Sherri Franklin
    8 years ago

    Yeah the DHE didnt work for me and was very hard to tolerate..

  • Crissy Diener
    8 years ago

    So what’s the news on this new med? Will it work faster or better? I work at a drs office and love talking to the drug reps. I’d love to know who is manufacturing this one to see if they know anything about it!

  • Rosa Sundquist
    8 years ago

    Hope this new drug gets approved. I use DHE it is the only med that helps, but the side effects are terrible. I give myself the injections here at home, always have to use Zofran or Phenergan at least 30 minutes before otherwise I get very sick to my stomach. The injections are very painful.. Ugh! DHE is much easier to use when I have a Picc Line in but it still has awful side effects.. I just finally gpt the Picc Line removed after 4 months and 4 days.. 🙂

  • Krista Furgerson
    8 years ago

    Rosa: I wouldn’t have thought of the ice pack if the nurse didn’t tell me. =D Minds on migraines don’t do logic. Louise: My doc has me do them subcutaneous too. Thanks for info about sodium chlordide!

  • Louise M. Houle
    8 years ago

    Suggestion: ask your doctor for a RX for Sodium Chloride, 10 ml multi-use vial; use a bigger syringe to mix 1.5 ml of sodium chloride with the DHE; this dilutes the solution and when you inject, there is almost no burning at all. The injections I do are sub-cutaneous though. Is that only here in Canada? Are yours intra-muscular? Either way. Diluting should help. I can give you more detail if you are interested. I also take an anti-nausea 20 minutes before injecting; and sometimes I need Immodium. Otherwise, it really helps control my daily migraines during my period only. The rest of the time I take Amerge.

  • Rosa Sundquist
    8 years ago

    Thanks for the advise Krista, I will try to use ice pack next time not sure why I never thought to use ice for the injection site I use ice packs daily for comfort and pain relief..

  • Krista Furgerson
    8 years ago

    Yes, they are painful! I use an ice pack to numb the area but it’s still quite unpleasant.

  • Megan Leitsinger
    8 years ago

    and how long does the NDA process take? I would be willing to try this. Sounds better than the IVs.

  • Diana Lee
    8 years ago

    Hopefully they will have made a decision within the next year. It can take a while.

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