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Expert commentary

by A. Laine Green, MSc, MD, FRCPC, FAHS

Prior to 2020 with the addition of gepants and a ditan for the acute treatment of migraine the usual medications used for the acute treatment of migraine included triptans, non-steroidal anti-inflammatories, and anti-emetics (that primarily had dopaminerigic activity). In patients not responsive to a single agent a combination of medications is sometimes used to achieve superior relief. In severe cases clinicians may combine a triptan, NSAID, and anti-emetic to more effectively treat a migraine attack. Medications can fail because of lack of efficacy or side effects. Thus, the more agents we have to pick from the better chances for the patient to achieve relief. Several NSAIDs have evidence for their use in the acute treatment of migraine but celecoxib does not have the same evidence. This study aimed to assess the efficacy and tolerability of a liquid formulation of celecoxib (DFN-15). The authors stated it was rapidly absorbed but did not provide information on this. They presented data on 2 identical multicenter randomized double blind placebo controlled pivotal trials on DFN-15. They recruited adult male and female subjects with an ICHD3-beta diagnosis of migraine who had 2-8 attacks per month and were not overusing acute treatments. Patients either received placebo or DFN-15 (liquid formulation of celecoxib 120 mg). Each study had over 600 subjects each. Co-primary end points are the standard endpoints dictated by the FDA: pain freedom at 2 hrs and freedom from most bothersome symptom MBS (nausea, photophobia, or phonophobia) at 2hrs. The first study, by the authors declaration, had a site with a disproportionate placebo response which resulted in a failure to meet statistical significance for the 2 hr pain free response. The second study reached statistical significance for 2 hr pain freedom with a point estimate of 35.6% of subjects reaching pain freedom at 2 hrs. Both studies met statistical significance for MBS freedom at 2 hrs. In both studies pain relief was in the 68-75% range. The most common side effect was bad taste and they reported no serious AE or deaths. These studies likely showed that DFN-15 a liquid formulation of celecoxib was efficacious and well tolerated. They may need to complete another study to the effects of an outlier site. Although not compared in a head to head fashion the results are not dissimilar to other medications used for the acute treatment of migraine. Having another NSAID (and a long acting NSAID) would be a useful tool for the acute treatment of migraine. It should be noted the presenter was an employee and stock holder for the company that owns DFN-15. This potentially introduces bias in to the presentation.

 


References 

  • Up To Date for celecoxib PK data
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