Since May 2018, within a period of just under two years, seven new medications for migraine treatment have received FDA approval and are available for routine clinical use. Our “Migraine Treatment of the Month” features the newest of the seven: rimegepant (Nurtec ODT; Biohaven Pharmaceuticals). 

In February of this year, the Nurtec oral disintegrating tablet ODT (rimegepant) received FDA approval for acute treatment of migraine. With no less than ten FDA-approved oral medications already available for acute treatment of migraine, one might wonder: is there really any need for yet another? 

Well...yes. For one thing, not everyone responds to these other medications. There may be problems with their tolerability, or they simply may not be effective. For some, there may be contraindications to their use. In particular, the triptans (eg, sumatriptan; Imitrex) have the potential for causing constriction of blood vessels, and many migraineurs have medical conditions that preclude triptan use. For these patients, Nurtec ODT may serve as an attractive alternative.

Nurtec exerts its effect in migraine by inhibiting the action of a protein, calcitonin gene-related peptide (CGRP), that is key to the transmission of head pain signaling within the migraine circuitry.  It does so by blocking the receptor to CGRP, thus "short-circuiting" the circuitry. 

Migraineurs have:

• an understandable desire to gain rapid relief from pain and the other annoying or even disabling symptoms that so often accompany migraine headache 

• a preference that this relief be achieved safely and without the price tag of bothersome side effects

• the hope that the relief initially obtained will persist without any need for re-treatment.

Thus the ideal treatment for acute migraine would be safe, well-tolerated, provide rapid onset of relief, and be associated with a low likelihood of early headache recurrence.  For many patients, Nurtec ODT may be that treatment.

In terms of headache reduction and complete freedom from headache, Nurtec ODT compares quite favorably with other available fast-onset oral medications. In the clinical research trials which earned Nurtec its FDA approval, about two-thirds of the participating migraine patients experienced a reduction in moderate-severe headache to mild or no pain within 2 hours of administering the medication; just over 20% percent were entirely pain-free. In fact, significantly more patients achieved pain relief at 1 hour than those taking placebo. Perhaps even more compelling, 86% of those patients who self-treated with Nurtec took no further medication for acute headache treatment over the 24 hours following its administration.

“Half-life” is the time required for the body to eliminate one half of any medication absorbed into the bloodstream. At 11 hours, Nurtec ODT’s half-life is more than double that of the fast-onset oral triptans.  When coupled with the clinical finding that relatively few migraineurs who administer Nurtec ODT appear to require any further treatment over the ensuing 24 hours, this pharmacokinetic feature of the drug suggests that for many migraineurs Nurtec ODT may serve as a "one and done" treatment. The prescribing information for Nurtec ODT also highlights that significantly more patients, after taking the medication, in the clinical trial returned to normal function at 2 hours vs. those who took a placebo and sustained that benefit for two days.

A side note: it deserves mentioning that data from recent clinical research indicate Nurtec is effective for migraine prevention as well as an acute treatment of migraine.  If the FDA approves Biohaven’s supplemental application for this indication, Nurtec will become the first medication indicated for both preventive and acute treatment of migraine.

Finally, Nurtec ODT appears to be both safe and extremely well-tolerated. Nausea, its most common side effect, was reported by only 2% of patients participating in clinical research trials.

For more information regarding Nurtec ODT and the patient assistance program related to filling prescriptions of the medication, go to nurtec.com

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