Frovatriptan (Frova™) Approved by FDA
 

The newest migraine treatment, (Frova™) 2.5-milligram tablets, is now widely available throughout the United States. Approved by the U.S. Food and Drug Administration for the acute treatment of migraine attacks with or without aura in adults, Frova (frovatriptan succinate) is from the well-known class of drugs called triptans. Frova, however, has a half-life of 26 hours, allowing its active ingredient to remain in the blood for at least 20 hours longer than any other triptan.

The debilitating headaches known as migraines are estimated to affect 25 to 30 million individuals in the United States, and are characterized by recurring symptoms of moderate to severe throbbing pain on one or both sides of the head, nausea, and sensitivity to light and sound. The average migraine lasts more than 24 hours, with a range of 4 to 72 hours. A recent study has shown that 7 of 10 migraine sufferers are dissatisfied with their current migraine treatment.

Frova treats the pain of a migraine by constricting targeted blood vessels in the brain. In clinical studies, less than half the patients taking Frova needed to augment the treatment of their pain with additional medications, including aspirin.

"Triptans have revolutionized the treatment of migraine and have helped millions with migraines live more normal lives," stated Roger K. Cady, M.D., of the Headache Care Center, Primary Care Network in Springfield, MO, and one of the investigators in the clinical trials of Frova. "However, despite these advances, there is still room for improvement, as not everyone gets adequate relief from their migraine treatment. One important reason is that many times the headache returns even after treatment."

The effectiveness and tolerability of Frova was demonstrated in five randomized, placebo-controlled clinical trials involving 4,129 patients. Compared to placebo, Frova significantly reduced migraine pain. Patients treated with Frova also reported significant relief of symptoms associated with migraines, including nausea and sensitivity to light and sound.

Only 1 percent of patients withdrew from the clinical trials because of adverse events, most of which were reported to be mild or moderate and transient. Adverse events that were reported by at least 2 percent of patients included dizziness, fatigue, paresthesia (a burning or prickling sensation), flushing, headache, dry mouth, hot or cold sensation and chest pain.