(frovatriptan succinate) Tablets
FROVA (frovatriptan succinate) tablets contain frovatriptan succinate, a selective 5-hydroxy-tryptamine1 (5-HT1B/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.
Published Studies Related to Frova (Frovatriptan)
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...
A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine. [2011.04]
The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1-3 attacks...
Frovatriptan as preemptive treatment for fasting-induced migraine. [2011.03]
OBJECTIVE: To examine frovatriptan's efficacy as preemptive treatment for fasting-induced migraine. BACKGROUND: Fasting is a common migraine trigger that cannot always be avoided. The development of a short-term preemptive approach would be of benefit. Because of its longer half-life, frovatriptan has been effectively used for short-term daily use to prevent menstrually related migraines and might prove useful in the prevention of fasting-induced migraine... CONCLUSION: More subjects on placebo developed a headache than those on frovatriptan. Perhaps because of the small number of subjects involved, the differences in headache incidences observed did not achieve statistical significance. (c) 2011 American Headache Society.
Frovatriptan for prophylactic treatment of cluster headache: lessons for future trial design. [2011.01]
OBJECTIVE: The aim of this study was to determine whether frovatriptan would show efficacy in short term prophylactic treatment of episodic cluster headache (ECH) in comparison to placebo. BACKGROUND: The 5-hydroxytryptamine(1B/d) (5-HT(1B/d) )-agonists naratriptan, eletriptan, and frovatriptan have been shown to reduce the frequency of ECH. So far, no double-blind placebo-controlled trials have investigated the potential prophylactic effects of 5-HT(1B/d) -agonists in ECH... CONCLUSION: This study shows that particular therapeutic aims are impossible to be addressed in a double-blind, randomized, parallel group, study design with specific inclusion and exclusion criteria according to the International Headache Society (IHS) guidelines for controlled trials of drugs in cluster headache. Further studies are required to evaluate the potential efficacy of triptans in the prophylactic treatment of ECH. The outcome of the trial suggests that the recommendations of the Guidelines for controlled Trials of Drugs in Cluster Headache from the IHS should be revised. (c) 2010 American Headache Society.
Clinical Trials Related to Frova (Frovatriptan)
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.
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 [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
This study is a prospective pilot trial. The study will last approximately 35-39 weeks.
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
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
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
Reports of Suspected Frova (Frovatriptan) Side Effects
Eye Pain (2),
Gait Disturbance (2),
Photosensitivity Reaction (1),
Circulating Anticoagulant (1),
Drug Ineffective (1),
Drug Interaction (1),
Optic Neuropathy (1), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Frova has an overall score of 8. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Frova review by 42 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|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|
|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.|
Page last updated: 2011-12-09