General Information

The FDA has approved Frova (frovatriptan succinate) for the acute treatment of migraine attacks with or without aura in adults. Frovatriptan, the active ingredient in Frova, works by binding to and stimulating serotonin (5-HT) receptors. Some scientists believe that migraines are caused by a constriction and sudden dilation of the blood vessels in the head, neck or scalp. Frova is believed to inhibit excessive dilation of the arteries associated with migraine attacks.

Frova offers a unique benefit in terms of its improved half-life. Migraine attacks generally last four to seventy-two hours. In contrast to currently marketed triptans, which have a half-life of six hours or less, Frova 2.5 mg tablets have a 26-hour half-life.

Clinical Results

Five randomized, double-blind, placebo-controlled, outpatient trials demonstrated the effectiveness of Frova in treating migraine headaches. Two of the trials were dose finding, in which subjects received doses of Frova from 0.5 to 40 mg, while the remaining three evaluated only one dose (2.5 mg).

In these controlled short-term trials, subjects were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed for up to 24 hours after dosing. Associated symptoms, such as nausea, vomiting, photophobia and phonophobia were also evaluated. In two of the trials, a second dose of Frova was provided after the initial treatment to counter a recurrence of the headache within 24 hours.

In all five of the trials, the percentage of subjects achieving a headache response two hours after treatment was significantly greater for the Frova-treated group compared to placebo-treated subjects. The data showed that lower doses of Frova (1 mg or 0.5 mg) were not effective, and higher doses (5 mg to 40 mg) caused a greater incidence of adverse events without being more effective than a 2.5 mg dose. Additionally, in subjects with migraine-associated nausea, photophobia and phonophobia at baseline, those treated with Frova experienced a decreased incidence of these symptoms compared to subjects receiving placebo.

Side Effects

Side effects associated with Frova include the following:

Dizziness

Fatigue

Tingling

Dry mouth

Hot flashes

Feeling hot or cold

Chest pain

Indigestion

Skeletal pain

Patients with the following conditions should not use Frova:

Uncontrolled high blood pressure

Heart disease

Hemiplegic or basilar migraine

History of stroke

Circulation problems

Mechanism of Action

Frovatriptan is a 5-HT receptor agonist that binds with high affinity to 5-HT1B and 5-HT1D receptors. Frovatriptan has no significant effects on GABA mediated channel activity and has no significant affinity for benzodiazepine binding sites. Frovatriptan is believed to inhibit excessive dilation of extracerebral intracranial arteries in migraine. In anesthetized dogs and cats, intravenous administration of frovatriptan produced selective constriction of the carotid vascular bed and had no effect on blood pressure or coronary resistance. (from Frova Prescribing Information)