Migraine and headache:
Indications for: NURTEC ODT
Acute treatment of migraine with or without aura. Preventive treatment of episodic migraine.
Acute Treatment of Migraine
Approval was based on efficacy data from a randomized, double-blind, placebo-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT03461757) that compared Nurtec ODT with placebo in 1466 adult patients for the acute treatment of migraine with and without aura. Patients were randomly assigned to receive Nurtec ODT 75mg once (n=732) or placebo (n=734). The primary endpoint was pain freedom and most bothersome symptom (MBS) freedom at 2 hours after dosing in patients who treated a migraine with moderate to severe pain.
Results demonstrated that a statistically significantly greater proportion of patients treated with Nurtec ODT achieved headache pain freedom (21.2% vs 10.9%; P <.001) and MBS freedom (35.1% vs 26.8%; P =.001) 2 hours after a single dose compared with placebo, respectively.
Nurtec ODT was associated with statistically significant improvements in key secondary endpoints when compared with placebo. These included the percentage of patients with pain relief at 2 hours (59.3% vs 43.3%; P <.001), sustained pain freedom at 2-48 hours (13.5% vs 5.4%; P <.001), use of rescue medication within 24 hours (14.2% vs 29.2%; P <.001), and those reporting normal function at 2 hours after dosing (38.1% vs 25.8%; P <.001). The incidence of photophobia and phonophobia was also reduced with Nurtec ODT vs placebo.
Preventive Treatment of Episodic Migraine
Approval was based on data from a randomized, double-blind, placebo-controlled phase 2/3 study (ClinicalTrials.gov Identifier: NCT03732638) that assessed the efficacy and safety of Nurtec ODT in adults who had migraines for at least 1 year and 4 to 18 moderate to severe migraine attacks per month over 3 months prior to enrollment.
Patients were randomly assigned to receive either Nurtec ODT 75mg orally every other day (n=373) or placebo (n=374). The primary endpoint was the change from baseline in the mean number of monthly migraine days (MMDs) during weeks 9 through 12 of the double-blind treatment phase.
Findings showed treatment with Nurtec ODT resulted in a statistically significant reduction in MMDs from baseline compared with placebo (-4.3 days vs -3.5 days; P<.010). Additionally, a larger percentage of Nurtec ODT-treated patients achieved at least a 50% reduction from baseline in moderate to severe MMDs during weeks 9 through 12 of the double-blind treatment phase (49.1% vs 41.5%; P=.044).
Allow tablet to dissolve on tongue. Acute: 75mg once as needed (max daily dose). Preventive: 75mg every other day. The safety of using more than 18 doses in a 30-day period has not been established.
NURTEC ODT Warnings/Precautions:
Discontinue if hypersensitivity reaction occurs; treat appropriately. Severe hepatic impairment (Child-Pugh C) or ESRD (CrCl <15mL/min): avoid. Dialysis: not studied. Pregnancy. Nursing mothers.
NURTEC ODT Classification:
Calcitonin gene-related peptide (CGRP) receptor antagonist.
NURTEC ODT Interactions:
Potentiated by strong CYP3A4 inhibitors (eg, itraconazole); avoid concomitant use. May be potentiated by moderate CYP3A4 or potent P-gp inhibitors (eg, amiodarone, cyclosporine, lapatinib, quinidine, ranolazine). Avoid another dose of Nurtec ODT within 48hrs when used with moderate CYP3A4 or potent P-gp inhibitors. May be antagonized by strong or moderate CYP3A inducers (eg, rifampin); avoid concomitant use.
Nausea; delayed serious hypersensitivity.
Fecal (78%), renal (24%). Half-life: ~11 hours.
Generic Drug Availability: