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.

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NEWS HIGHLIGHTS

Published Studies Related to Frova (Frovatriptan)

Gender and triptan efficacy: a pooled analysis of three double-blind, randomized, crossover, multicenter, Italian studies comparing frovatriptan vs. other triptans. [2014]
Migraine is three times as common in females as in males, and attacks may be more severe and difficult to treat in women. However, no study specifically addressed possible gender differences in response to antimigraine therapy.Although migraine presents in a more severe form in women, frovatriptan seems to retain its good efficacy and favorable sustained antimigraine effect regardless of the gender.

Efficacy of frovatriptan and other triptans in the treatment of acute migraine of hypertensive and normotensive subjects: a review of randomized studies. [2013]
Migraine might be associated with high blood pressure (BP), which can cause more severe and more difficult to treat forms of headache... However, frovatriptan, in contrast to other triptans, seems to have a sustained antimigraine effect in both HT and NT patients.

Frovatriptan vs. other triptans for the acute treatment of oral contraceptive-induced menstrual migraine: pooled analysis of three double-blind, randomized, crossover, multicenter studies. [2013]
Oral contraceptive-induced menstrual migraine (OCMM) is a particularly severe form of migraine triggered by the cyclic hormone withdrawal. To review the efficacy of frovatriptan vs...

A double-blind, randomized, multicenter, Italian study of frovatriptan versus almotriptan for the acute treatment of migraine. [2011.06]
The objective of this study was to evaluate patients' satisfaction with acute treatment of migraine with frovatriptan or almotriptan by preference questionnaire. One hundred and thirty three subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or almotriptan 12.5 mg, treating 1-3 attacks...

Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, multicenter, Italian, comparative study versus zolmitriptan. [2011.05]
Menstrually related migraine (MRM) is a particularly difficult-to-treat pain condition, associated with substantial disability. Aim of this study was to compare the efficacy and safety of frovatriptan and zolmitriptan in the treatment of MRM attacks, analyzing data from a multicenter, randomized, double blind, cross-over study...

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Clinical Trials Related to Frova (Frovatriptan)

Frovatriptan and Menstrual Migraine [Terminated]
We are looking for women who suffer from menstrual migraine to participate in a 2-visit migraine brain imaging research study. Our goal is to see how the menstrual migraine brain's pain pathways function when the migraineur has been taking Frovatriptan. During the screening visit (Visit 1) participants will sign the informed consent form, complete questionnaires, meet with the study physician, and have QST (quantitative sensory testing: to determine your pain thresholds for a heat stimulus) performed. For Visit 2's MRI scan, subjects will be asked to lie very still while the scan is occurring. In some parts, they will not have to do anything, while in others they will be asked to rate pain and unpleasantness for brush and thermal stimuli. Participants are compensated for both visits.

Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine [Completed]
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.

Frovatriptan as a Transitional Therapy in Medication Overuse Headache [Recruiting]
This study will analyze the effectiveness of a medication called Frovatriptan, in the context of medication overuse headache (MOH). MOH is a headache that develops when pain-killers are taken frequently. The treatment is to stop the overuse of these pain-killers, but that can sometimes worsen the headache first before it gets better. We are testing Frovatriptan against placebo to see if it can help patients with this transition and avoid the worsening of the headache that can occur. We will also see if Frovatriptan can help in other ways, such as maintain patients free of medication overuse.

Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals [Completed]
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.

A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting [Completed]
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.

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Reports of Suspected Frova (Frovatriptan) Side Effects

Headache (2),  Migraine (2),  Eye Pain (2),  Gait Disturbance (2),  Asthenia (2),  Photosensitivity Reaction (1),  Circulating Anticoagulant (1),  Drug Ineffective (1),  Drug Interaction (1),  Optic Neuropathy (1), more >>

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.