Migraine Treatment of the Month: Tosymra
Ever since injectable sumatriptan was released (as Imitrex) for general clinical use in 1992, investigators have searched for a needle-less alternative for delivery of a triptan or triptan-like medication which would offer the same level of effectiveness, the same rapidity of effectiveness and the advantage of avoiding the oral route of administration in migraineurs experiencing nausea and vomiting with their headaches.
We have witnessed a parade of such alternatives: intranasal sumatriptan and zolmitriptan, Migranal (intranasal dihydroergotamine), Sumavel (needle-free injectable sumatriptan), Zecuity (sumatriptan delivered via a transdermal patch) and Onzetra (sumatriptan delivered via an "exhalant" mechanism). With the exception of Zecuity (which was taken off the market due to its potential for causing burn injury), each continues to be used successfully by many patients. Even so, for various reasons none has really come close to knocking injectable sumatriptan off its perch as the treatment for self-administered rescue from moderate to severe migraine headache and associated nausea, vomiting and light/sound sensitivity.
In late January the FDA approved a new medication, Tosymra, for the acute treatment of migraine. Tosymra is a nasal spray which delivers 10 mg of sumatriptan intranasally, with 1 spray delivered into one nostril. Patients may use up to 30 mg within a given 24-hour period. The medications label contains the usual warnings regarding triptan use in patients who have or may have heart disease, stroke or other medical disorders which at least theoretically could put them at risk for a drug-related vascular complication.
How well does it work? While we know from experience that results from clinical research studies cannot always be duplicated in “real world" clinical practice, in one study over 40% of participants with moderate to severe acute migraine headache were headache-free by 2 hours following administration of the drug. "Headache-free" is a high bar to reach; all FDA-approved triptans on the market have returned that approval on the basis of studies using "pain relief" as a primary endpoint for clinical outcome (i.e., what percentage of patients with moderate to severe headache had no or mild headache within 2 hours of study drug administration), and with the oral triptans that percentage generally hovered between 50 and 60%. Tosymra’s pain-free percentage of 44% at 2 hours approaches what one would expect from injectable sumatriptan.
It will take the experience from real world clinical practice to know, but hopefully Tosymra will represent an attractive alternative to injectable sumatriptan for those patients who prefer a non-injectable therapy for migraine headache "rescue".