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General Information
Frova (frovatriptan succinate) is a serotonin (5-HT1B/1D) receptor agonist (triptan).
Frova is specifically indicated for the acute treatment of migraine with or without aura in adults.
Frova is supplied as tablets for oral administration. The recommended dose is a single tablet (2.5 mg) taken orally with fluids. If the migraine recurs after initial relief, a second tablet may be taken, providing there is an interval of at least 2 hours between doses.
The total daily dose should not exceed 3 tablets (3 × 2.5 mg per 24-hour period). There is no evidence that a second dose of Frova is effective in patients who do not respond to a first dose of the drug for the same headache. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
Mechanism of Action
Frovatriptan binds with high affinity to 5-HT1B/1D receptors. The therapeutic activity of FROVA is thought to be due to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
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
Clinical Trial 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.