my personal edition > migraine > news


  E-Mail this DGNews to a colleague

DGNews

Frova (Frovatriptan Succinate) For Menstrual Migraine Prophylaxis Effective, Well Tolerated: Presented at AHS

Efficacy and Tolerability of Frova Were Not Altered by Oral Contraceptive Use and Risk of Rebound Headache Did Not Increase

CHICAGO, IL and SAN DIEGO, CA -- June 23, 2003 -- Elan Pharmaceuticals, Inc. and UCB Pharma, Inc. announced Friday that two new studies presented at the American Headache Society annual meeting showed that prophylactic use of Frova™(frovatriptan succinate)* is effective and well-tolerated in preventing menstrually associated migraines when dosed at 2.5 mg once a day or 2.5 mg twice a day. The studies also showed that the dose regimen did not appear to increase risk of rebound migraine frequency and that the efficacy and tolerability of Frova were not affected by oral contraceptive use.

Frova is approved by the U.S. Food and Drug Administration for the acute treatment of migraine attacks with or without aura in adults. Frova is a triptan, a class of drugs commonly used to treat migraines by acting on receptors in specific blood vessels in the brain thought to cause pain.

Migraines affect an estimated 21 million American women [1], and approximately 60 percent of them, or nearly 13 million, report an increased number of headaches around the time of their periods [2], a condition known as menstrually associated migraine.

Data for the studies were collected in a 36-site trial of 546 women, mean age 37.6 years, having a mean frequency of menstrually associated migraine of 11.4 attacks in the previous 12 months. The intent to treat efficacy population consisted of 506 patients who treated at least one perimenstrual period; 443 patients treated three perimenstrual periods and completed the study.

The first study, presented by Richard Singer, M.D., a practicing neurologist and president of Neurology Clinical Research in Plantation, Fla., found that Frova 2.5 mg administered once or twice daily was significantly superior to placebo in preventing menstrually associated migraine headaches (P<.0001) regardless of whether or not oral contraceptives were used.

525 percent of those not using oral contraceptives and 50.3 percent of those using oral contraceptives had no incidence of menstrually associated migraine on twice-daily Frova. On once daily Frova, 36.8 percent of those not using oral contraceptives and 46.8 percent of those using oral contraceptives experienced no menstrually associated migraines. Of those taking placebo, 27.7 percent of those taking oral contraceptives and 23.3 percent of those not taking oral contraceptives did not experience menstrually associated migraines.

Headache severity and duration were reduced by both treatment regimens, regardless of oral contraceptive use. For oral contraceptive users, mean total headache duration was 32.6 hours (placebo), 19.1 hours (Frova once daily) and 18.2 hours (Frova twice daily). For nonusers, mean total headache duration was 30.3 hours (placebo), 21.0 hours (Frova once daily), and 15.7 hours (Frova twice daily).

Frova also reduced functional disability and the need for rescue medication in both oral contraceptive users and nonusers, and was equally well tolerated in both patient populations. In addition, the incidence of adverse events was similar for both groups during each dosing regimen. Adverse events did not increase with Frova 2.5 mg twice daily compared to Frova 2.5 mg once daily for either oral contraceptive users or non-users.

"Because many women take oral contraceptives and also suffer from migraines, physicians are often concerned with potential interactions with other drugs, including triptans," said Dr. Singer.

The second study, presented by Stewart Tepper, MD., director of the New England Center for Headache in Stamford, Conn., examined the use of Frova to prevent menstrually associated migraine, specifically evaluating the risk of rebound migraine attacks. A rebound headache occurs when headache medications wear off in patients who have overused them and become dependent. It is characterized by continuous, dull headache pain throughout the day, punctuated by periods of increased pain.

There was no evidence of rebound increase in migraine incidence in the five days after dosing for any of the three treatment regimens. During the study, the mean frequency of migraines not occurring with menstruation was lower than was reported at baseline (one attack per 28 days), and similar for the three treatment regimens (placebo, Frova 2.5 mg once daily, Frova 2.5 mg twice daily), ranging from 0.4 to 0.6 attacks per 28 days.

"Rebound can be a significant problem in people who take acute medications frequently, as needed for their headaches," said Dr. Tepper.

About Frova
The efficacy and tolerability of Frova was demonstrated in five randomized, placebo-controlled clinical trials of 4,129 patients. Frova significantly reduced migraine pain versus placebo.

Patients treated with Frova also reported significant relief in symptoms associated with migraines, including nausea and sensitivity to light and sound. Available in 2.5 mg tablets, Frova should be taken with fluids at the onset of a migraine. If adequate headache relief is not achieved with the first dose, a second dose may be taken two hours later. Only one percent of patients withdrew from Frova 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 two percent of patients included dizziness, fatigue, paresthesia (a burning or prickling sensation), flushing, headache, dry mouth, hot or cold sensation and chest pain.


SOURCE: Ketchum

E-Mail this DGNews to a colleague

To print, use this version