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
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