FDA Issues New Guidelines for Developing Abortive Migraine Meds

Recently, the FDA provided new guidelines for all new Migraine medications that are being developed. Any new drug would have to provide evidence that it eliminates headache pain within 2 hours of taking the drug. The drug would also have to improve at least one of the most “bothersome migraine associated symptoms,” as identified by the patient- such as photophobia, nausea or phonophobia. To be approved, the drug would have to meet both criteria.

The previous guidelines only required a reduction in pain after 2 hours (not elimination of pain), which is an improvement in creating a new class of Migraine medications. The new guidelines are targeted toward acute or abortive Migraine drugs. Additional guidelines for preventative Migraine drugs are expected soon.

During the trial stages for new Migraine drugs, the FDA is requiring trials of at least 300 patients using the drug for six months and 100 patients using it for one year. While all drugs affect patients differently, a substantial amount of the patients studied will have to report no pain after 2 hours and reduction in at least one Migraine symptom (other than pain).

Due to the high prevalence of Migraine in children, during Phase II trials, children between the ages of 6 – 17 must be included in studies as well. Since Migraine symptoms and effects can change with puberty, separate studies should be conducted for patients “aged 6 to 11 years and 12 to 17 years to characterize adequately the safety and efficacy of the drug in these 2 age groups.”  The pediatric trials will help with the development of age-appropriate dosing and to determine if the drug is safe for use in children and at what age.

It is recommended that the drug be taken as soon as a Migraine is presented to determine efficacy, but the time from when the Migraine begins to when the drug is taken will also need to be studied. While one dose is preferable to reach a no-pain endpoint within 2 hours, re-dosing within that time period should also be studied to identify optimal dosing. Evidence of relapse in Migraine within 24 or 48 hours should also be used as a measure of success.

As mentioned, the drug must also reduce at least one of the three Migraine symptoms (photophobia, nausea or phonophobia). The drug-maker can chose to address any of these three based on their trial objectives and intended claims in labeling.

The majority of Triptans, the most common type of medication used to abort Migraines, were developed in the 1990s and are now available in generic form. Triptans include Imitrex, Maxalt, Zomig. Pharma companies see significant revenue decrease once a drug goes off-patent, which is typically 20 years after receiving patent protection. Because these drugs are now generic, the manufacturers have an incentive to try to find new formulations and increase the efficacy of any new drug they develop.

If you are interested in being part of a clinical trial for new Migraine medications or to be on a list for future trials, visit http://www.nih.gov/health/clinicaltrials/findingatrial.htm

A copy of the new guidelines can be found here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM419465.pdf

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.

Comments

View Comments (6)
  • Ellen H
    4 years ago

    What happens to those of us who are missing the important Liver Enzymes that are needed to metabolize medications and other substances in the first place??? When the liver cannot metabolize the meds, the drug builds up in your system and becomes toxic, therefore producing serious adverse side effects.

    I have been on over five dozen migraine medications in the last twenty years. Many of the meds made me quite ill. The others simply did nothing at all. We have also tried two nerve blocks and one attempt at temporary electrode implants. I am also not a good candidate for botox, though I would never let anyone stick needles in my face!!!

    I wonder about the people who fail these trials, are any of them also missing liver enzymes? Do the drug companies even take this into consideration???

    I told my doctor recently, I am done trying anything new. I can’t take it anymore.

    Have any of the rest of you experienced severe side effects from medications??? Are you missing the Liver Enzymes needed to metabolize medications?

  • lovesthequiet
    4 years ago

    This is a concern for me. Many of us with severe lasting migraines (8+ pain level for 3 or 4 days) would never be able to participate in this kind of study because the drug would always “fail” for us. I don’t think there is anything that can bring me to a pain level of zero after two hours, but I don’t expect that. If I can get to a pain level of 2 or 3 that is acceptable and I can function. By adding on the requirement to also address a second symptom we are going to end up with another 2 ingredient medication (maybe a mix with phenergan or zofran or something) when that second ingredient may not be the right combo for the individual migraineur. By keeping each medication for each symptom “a la carte” you allow for the patient, who knows their headaches best, to pick the right medications for that individual headache. If you need to go to work, you might take zofran for nausea because it won’t make you sleepy. If you are home for the day and really suffering, you may opt for phenergan, a heavier medication that will quell the nausea, allow you to get some sleep and not affect driving or work performance. Drug companies don’t allow you that flexibility when they decide to bundle medications in one pill.

  • cosmicbabe
    4 years ago

    I’m excited about this because I can only use 1 triptan without horrible side effects, and it almost always takes more than 2 hours for 80% relief (and at least 20% of the time, doesn’t help much at all). My adult daughter can’t take triptans at all, so she is stuck using Butalbitol & Toradol which aren’t actually migraine medications and don’t often help all that much.

  • Jean
    4 years ago

    I fear no new drug will pass this new stringent guideline. None of my current abortives or ones I have used in the past ever totally alleviated my pain in 2 hours except Demerol which I cannot use anymore for risk of rebound headaches.

  • Tammy Rome
    4 years ago

    Maybe these new guidelines will prevent pharmaceutical companies from producing more “me too” triptans and actually create something new that helps those for whom triptans never work or aren’t safe.

  • Sandy
    4 years ago

    that is awesome. none of the abortive meds never worked well for me. I could never identify any warning signs, aura, etc. Now that I am having chronic migraines, i am beginning to understand my symptoms better.

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