Migraine and headache:
Indications for: ZOMIG NASAL SPRAY
Acute treatment of migraine with or without aura.
Limitations of Use:
Use only after a clear diagnosis of migraine has been established. Not indicated for the prevention of migraine attacks. Safety and effectiveness of Zomig have not been established for cluster headache. Nasal Spray: also, not recommended in patients with moderate to severe hepatic impairment.
Zomig Nasal Spray (Adults)
The efficacy of Zomig nasal spray 2.5 mg and 5 mg in the acute treatment of migraine headache with or without aura in adults was demonstrated in Study 1, a randomized, outpatient, double-blind, placebo-controlled trial.
In Study 1, patients were instructed to treat a moderate to severe headache. Headache response was defined as a reduction in headache severity from moderate or severe pain to mild or no pain, and was assessed 15, 30, 45 minutes and 1, 2, and 4 hours after dosing. Patients were allowed to take a dose of escape medication at 4 to 24 hours after the initial treatment for persistent and recurrent headache.
Results showed that the 2-hour headache response rates in patients treated with Zomig nasal spray 2.5 mg and 5 mg were significantly higher compared with placebo, 55% and 69% vs 31%, respectively (P <.001).
Among patients with migraine associated photophobia, phonophobia, and nausea at baseline, treatment with Zomig nasal spray achieved a decreased incidence of these symptoms compared with placebo.
The efficacy of Zomig was unaffected by presence of aura; presence of headache upon awakening, relationship to menses; gender, age or weight of the patient; or presence of pretreatment nausea.
The efficacy of Zomig nasal spray 5 mg was further supported by an interim analysis of another similarly designed trial. The 2-hour headache response rates for the first 210 subjects in that study for Zomig 5 mg and placebo were 70% and 47%, respectively (N=108 and 102, respectively, P =.0006).
Zomig Nasal Spray (Pediatric Patients 12 to 17 Years of Age)
The efficacy of Zomig nasal spray 2.5 mg or 5 mg in the acute treatment of migraine headache with or without aura in pediatrics patients 12 to 17 years of age was demonstrated in Study 2, a randomized, double-blind, placebo-controlled trial with a single-blind run-in period.
Patients had to have an established diagnosis of migraine (history indicating the presence of migraine for at least 1 year) with or without aura with a typical untreated migraine headache attack lasting 3 hours or more. The study included treatment of a single migraine headache attack with 1 dose of single-blind placebo during the 30-day run-in period. If the patient met all conditions for randomization, including a lack of response to the placebo run-in, a subsequent single migraine headache attack was treated with 1 blinded dose of either Zomig nasal spray 5 mg, 2.5 mg, or matching placebo.
Headache response was defined as a reduction in migraine-related headache pain severity from moderate or severe pain to mild or no pain, and the absence of nausea, photophobia, and phonophobia at 2 hours post treatment were also assessed.
The following results showed the proportion of pediatric patients who received Zomig 2.5 mg and 5 mg achieved no headache pain at 2 hours after treatment compared with placebo, respectively:
No headache pain: 25% and 30% (P <.05) vs 17%
With headache response: 53% (P <.05) and 51% (P <.05) vs 30%
No photophobia: 66% (P <.05) and 56% (P <.05) vs 44%
No phonophobia: 61% (P <.05) and 58% (P <.05) vs 48%
No nausea: 70% and 72% vs 66%
Initially 2.5mg once; max single dose: 5mg. If headache returns, may repeat once after 2 hrs; max 10mg/day. Reevaluate if no response after 1st dose. The safety of treating an average of more than 4 headaches in a 30-day period has not been established. Moderate to severe hepatic impairment: not recommended; use alternate formulation. Concomitant cimetidine: max single dose: 2.5mg, not to exceed 5mg in 24hr period.
<12yrs: not established.
ZOMIG NASAL SPRAY Contraindications:
Ischemic coronary artery disease disease (angina pectoris, history of MI, documented silent ischemia). Other significant underlying cardiovascular disease. Coronary artery vasospasm (eg, Prinzmetal's angina). Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. History of stroke, TIA, or hemiplegic or basilar migraine. Peripheral vascular disease. Ischemic bowel disease. Uncontrolled hypertension. Within 24 hours of ergot-type drugs or other 5-HT1 agonists. During or within 2 weeks after discontinuing MAOIs (type A).
ZOMIG NASAL SPRAY Warnings/Precautions:
Confirm diagnosis. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with likelihood of unrecognized coronary disease (eg, postmenopausal women, men over age 40, hypertension, hypercholesterolemia, obesity, diabetes, smokers, strong family history). Discontinue if disturbances in cardiac rhythm occur. Rule out vasospastic reaction before receiving additional doses. Monitor cardiovascular function in long-term intermittent use. Medication overuse headache: detox may be needed. Hepatic dysfunction. Monitor BP. Elderly. Pregnancy. Nursing mothers.
ZOMIG NASAL SPRAY Classification:
Selective 5-HT1B/1D receptor agonist.
ZOMIG NASAL SPRAY Interactions:
MAOIs (type A), methysergide, other ergotamines, other 5-HT1 agonists: see Contraindications. Serotonin syndrome with SSRIs, SNRIs, TCAs, MAOIs; discontinue if suspected. Absorption and half-life increased by cimetidine.
Neck/throat/jaw pain/tightness/pressure, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, dry mouth; rare: serious cardiac events. Nasal spray: also taste disturbances, local reactions.
Mean total plasma clearance for zolmitriptan nasal spray is 25.9 mL/min/kg, of which one-sixth is renal clearance. The renal clearance is greater than the glomerular filtration rate suggesting renal tubular secretion.
Generic Drug Availability:
Tabs (YES); ZMT tabs, sprayer (NO)
Tabs, ZMT tabs 2.5mg—6; Tabs, ZMT tabs 5mg—3; Single-dose sprayer—6