Migraine and headache:

Indications for: FROVA

Acute treatment of migraine.

Limitations of Use:

Confirm diagnosis. Not established for cluster headaches. Do not use for migraine prophylaxis.

Clinical Trials:

  • The efficacy of Frova was established in 4 randomized, double-blind, placebo-controlled, short-term outpatient trials. Patients were randomly assigned to receive doses of frovatriptan from 0.5mg to 40mg. 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 for up to 24 hours after dosing. Maintenance of response was assessed for up to 24 hours post dose.

  • In all 4 trials, a greater proportion of patients treated with frovatriptan 2.5mg achievd a headache response 2 hours after treatment compared with those treated with placebo, respectively:

    • Study 1:  42% vs 22% (P <.05)

    • Study 2:  39% vs 21% (P <.05)

    • Study 3:  46% vs 27% (P <.001)

    • Study 4:  37% vs 23% (P <.001)

  • The lower doses of frovatriptan (0.5mg or 1mg) were not effective at 2 hours. The higher doses of frovatriptan (5mg to 40mg) did not have an added benefit over 2.5mg.

  • There was a decreased incidence of migraine-associated nausea, photophobia, and phonophobia in patients who received Frova compared with placebo.

Adult Dosage:

≥18yrs: 2.5mg with fluids; may repeat once after 2 hours; max 7.5mg/24 hours. 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.

Children Dosage:

<18yrs: not recommended.

FROVA Contraindications:

Ischemic coronary artery disease (eg, angina pectoris, silent ischemia, history of MI). Coronary artery vasospasm (eg, Prinzmetal's variant angina). Uncontrolled hypertension. Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac conduction pathway disorders. History of stroke or transient ischemic attack (TIA). History of basilar or hemiplegic migraine. Peripheral vascular disease. Ischemic bowel disease. Within 24 hours of other 5-HT1 agonists or ergot-type drugs.

FROVA Warnings/Precautions:

Confirm diagnosis. Exclude underlying cardiovascular disease, supervise 1st dose, 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). Monitor cardiovascular function in long-term intermittent use. Peripheral vascular or colonic ischemia after other 5-HT1 agonists. Severe hepatic impairment. Elderly. Pregnancy. Nursing mothers.

FROVA Classification:

Selective 5-HT1B/1D receptor agonist.

FROVA Interactions:

Methysergide, other ergotamines, or other 5-HT1 agonists: see Contraindications. Serotonin syndrome with SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline).

Adverse Reactions:

Dizziness, paresthesia, dry mouth, fatigue, flushing, hot or cold sensation, dyspepsia, skeletal pain, chest/throat/neck symptoms (pain, pressure, tightness); serious cardiac events (rare).

Metabolism:

In vitro, cytochrome P450 1A2 appears to be the principal enzyme involved in the metabolism of frovatriptan. 

Drug Elimination:

Following administration of a single oral dose of radiolabeled frovatriptan 2.5 mg to healthy male and female subjects, 32% of the dose was recovered in urine and 62% in feces. The mean terminal elimination half-life of frovatriptan in both males and females is approximately 26 hours. 

Generic Drug Availability:

YES

How Supplied:

Tabs—9, 100