FROVA (frovatriptan succinate) · ENDO OPERATIONS

The pharmacokinetics of frovatriptan are similar in migraine patients and healthy subjects.

AbsorptionMean maximum blood concentrations (C max ) in patients are achieved approximately 2 to 4 hours after administration of a single oral dose of frovatriptan 2.5 mg. The absolute bioavailability of an oral dose of frovatriptan 2.5 mg in healthy subjects is about 20% in males and 30% in females. Food has no significant effect on the bioavailability of frovatriptan, but delays t max by one hour. Dist...

The efficacy of frovatriptan in the acute treatment of migraine headaches was demonstrated in four randomized, double-blind, placebo-controlled, short-term outpatient trials. In these trials, patients received doses of frovatriptan from 0.5 mg to 40 mg. In these controlled short-term trials, patients were predominately female (88%) and Caucasian (94%) with a mean age of 42 years (range 18 to 69). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed for up to ...

The following serious adverse reactions are described elsewhere in other sections of the labeling:

• Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina [see Warnings and Precautions ( 5.1 )]
• Arrhythmias [see Warnings and Precautions ( 5.2 )]
• Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions ( 5.3 )]
• Cerebrovascular Events [see Warnings and Precautions ( 5.4 )]
• Other Vasospasm Reactions [see Warnings and Precautions ( 5.5 )]
• Medicatio...

Frovatriptan succinate tablets are contraindicated in patients with:

• Ischemic coronary artery disease (CAD) (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia), or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions ( 5.1 )].
• Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction p...

• Myocardial ischemia/infarction or Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 )
• Arrhythmias: Discontinue frovatriptan succinate if occurs ( 5.2 )
• Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate high risk patients for coronary artery disease ( 5.3 )
• Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue frovatriptan succinate if occurs (...

7 DRUG INTERACTIONS 7.1 Ergot-containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and frovatriptan within 24 hours of each other is contraindicated [see Contraindications ( 4 ) ]. 7.2 5-HT 1B/1D Agonists Because the...