Frova (Frovatriptan Succinate) - Summary

FROVA SUMMARY

FROVA^®
(frovatriptan succinate) Tablets

FROVA (frovatriptan succinate) tablets contain frovatriptan succinate, a selective 5-hydroxy-tryptamine₁ (5-HT_1B/1D) receptor subtype agonist, as the active ingredient.

FROVA is indicated for the acute treatment of migraine attacks with or without aura in adults.

FROVA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). The safety and effectiveness of FROVA have not been established for cluster headache, which is present in an older, predominately male, population.

See all indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Frova (Frovatriptan)

Short-term frovatriptan for the prevention of difficult-to-treat menstrual migraine attacks. [2009.11]
The efficacy of a 6-day regimen of frovatriptan for menstrual migraine (MM; attacks starting on day -2 to +3 of menses) prevention in women with difficult-to-treat MM was assessed. Women with a documented inadequate response to triptans for acute MM treatment were included in this placebo-controlled, parallel-group trial.

Safety and tolerability of short-term preventive frovatriptan: a combined analysis. [2009.10]
OBJECTIVE: To assess the safety and tolerability profile of the 5-HT(1B/1D) agonist frovatriptan (Frova(R), Endo Pharmaceuticals Inc., Chadds Ford, PA, USA) when used as a 6-day regimen for the short-term prevention of menstrual migraine scheduled over multiple perimenstrual periods. BACKGROUND: Two randomized controlled trials have established the efficacy of a 6-day regimen of frovatriptan for reducing the incidence and severity of menstrual migraine over 1 to 3 perimenstrual periods; long-term data are needed to further assess the safety and tolerability profile of this regimen... CONCLUSIONS: During treatment of up to 12 perimenstrual periods over a 12- to 15-month period, the safety and tolerability of frovatriptan for short-term prevention of menstrual migraine was similar to that observed with acute use of triptans. Adverse events were generally mild or moderate in severity, there was no evidence of an increased risk of cardiovascular adverse events relative to acute treatment, and rebound headache was not evident. A short-term regimen with frovatriptan presents a safe and viable treatment option for preventing predictable migraine such as menstrual migraine.

Scheduled short-term prevention with frovatriptan for migraine occurring exclusively in association with menstruation. [2009.10]
OBJECTIVE: This post hoc subgroup analysis evaluated scheduled short-term preventive frovatriptan therapy for women with migraine occurring exclusively in association with menstruation (occurring day -2 to +3; day 1 = menses start, no migraines outside this window). BACKGROUND: A previously published randomized, double-blind, placebo-controlled 3-way crossover trial assessed the efficacy and safety of a scheduled 6-day preventive regimen with frovatriptan for the treatment of menstrual migraine; the study population included women experiencing both menstrual and non-menstrual migraine and women experiencing only menstrual migraine... CONCLUSIONS: Scheduled short-term preventive frovatriptan therapy effectively reduced the occurrence of menstrual migraine in women with attacks occurring exclusively in association with menstruation.

Pharmacokinetics of two 6-day frovatriptan dosing regimens used for the short-term prevention of menstrual migraine: A phase I, randomized, double-blind, placebo-controlled, two-period crossover, single-centre study in healthy female volunteers. [2009]
OBJECTIVE: This study aimed to assess the pharmacokinetics and tolerability of once- and twice-daily frovatriptan given for 6 days, a regimen that has previously been reported to reduce the incidence and severity of menstrual migraine when administered during the perimenstrual period... CONCLUSION: Both frovatriptan regimens achieved steady-state therapeutic blood concentrations by day 2. Twice-daily dosing maintained more consistent drug concentrations than once-daily dosing and was well tolerated.

Clinical and Economic Comparison of Frovatriptan Versus other Oral Triptans in the Treatment of Acute Migraine in the Real-World Setting. [2009.11.01]
Triptans (serotonin 5-HT(1B/1D) receptor agonists) such as frovatriptan have been shown to be highly effective and well tolerated in the treatment of patients with acute migraine. However, the large number of available triptans has led to the issue of how best to decide which triptan should be prescribed at an individual patient level...

more studies >>

Clinical Trials Related to Frova (Frovatriptan)

Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals [Recruiting]
This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental frovatriptan therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAM). The subjects enrolling in the study will have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs, the subject will institute a 4-day hormone-free interval (HFI). In an attempt to prevent/lessen the severity of headache during the HFI, subjects will be randomized to prophylactic administration of a triptan or placebo during this period. If no BTB/BTS occurs after 80 days of continuous pills, the subject will institute a 4-day HFI during which they will be randomized into triptan or placebo groups.

The purpose of this research study is to examine the effects of continuous oral contraceptive pills and frovatriptan on headaches that occur around the time of your period. Many woman take continuous oral contraceptive pills (OC) and when OCs are stopped they may get headaches. This study will look if taking frovatriptan around the time of the period will affect the headache, and how it will be affected. Frovatriptan is an FDA approved drug for migraine headaches.

This study is a prospective pilot trial. The study will last approximately 35-39 weeks.

Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine [Recruiting]
Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3. This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.

A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine [Completed]
Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle.

Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.

A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine [Completed]
The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Secondary objectives included determining the effectiveness of frovatriptan in reducing the incidence, severity and duration of MAM headaches and associated symptoms, to evaluate the safety and tolerability of the two frovatriptan dosing regimens and to compare the effectiveness of these regimens in the prevention of MAM headaches. In this cross-over study, patients treated each of 3 perimenstrual periods (PMPs) with placebo, frovatriptan 2. 5 mg daily (QD) and 2. 5 mg twice daily (BID) for 6 days, starting 2 days before the anticipated onset of a MAM headache.

A statistically significant reduction in the incidence of MAM headache (p<0. 0001) was observed with both dosing regimens of frovatriptan when compared to placebo. Additionally, the frovatriptan BID regimen was superior to the frovatriptan QD regimen in the prevention of MAM headache (p<0. 001). Significant reductions in MAM headache severity and duration, the incidence of associated symptoms and characteristics, and the use of rescue medication were observed when the PMP was treated with frovatriptan, compared to placebo. Both dose regimens of frovatriptan were equally well tolerated and no cardiovascular or other safety and tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.

A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting [Recruiting]
We are testing the hypothesis that subjects in the treatment group will experience fewer fasting induced headaches as compared to those in the placebo group. In our clinical experience, we estimate that approximately 25% of our headache population experiences fasting-induced migraine or hunger-induced migraine. With a given migraine incidence of 28 million in the United States alone, we estimate that approximately 7 million will experience hunger as a migraine trigger. If an individual has a known migraine trigger, then there are a variety of ways to modify care in order to address that trigger. The simplest is to avoid that trigger or preemptively treat that trigger. Frovatriptan has good evidence for daily use for a short time to help prevent menstrually related migraines. A short course of treatment can often avoid the initiation of the migraine and improve quality of life. Knowing that a longer acting triptan, such as frovatriptan, has demonstrated capability at suppressing headache through a known trigger, suggests the need to study this with fasting induced migraines, as well.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Frova review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Migraine Headache
Dosage & duration:		2.5 mg taken as needed for the period of 2 years
Other conditions:		none
Other drugs taken:		maxalt 10 mg
		Reported Results
Benefits:		Frova eliminated Migraine Headaches and the effect would last 24 hours.
Side effects:		The effect was slow. Approximately one or two hours before any significant pain relief was noticed. Also, some nausea from the drug.
Comments:		As soon as a migraine was detected a Frova would be administered. If the migraine was intercepted immediately the Frova was succesful with relieving pain and the chance of a rebound headache was slim. If a frova was not administered immediately a maxalt was taken then two hours afterwards a frova. This would eliminate pain for twenty four to thirty hours. On occasion a rebound headache would occur.