Frovatriptan

Frovatriptan (trade name Frova) is a triptan drug developed by Vernalis for the treatment of migraine headaches and for short term prevention of menstrual migraine. The product is licensed to Endo Pharmaceuticals in North America and Menarini in Europe.

Pharmacology
Frovatriptan inhibits excessive dilation of arteries that supply blood to the head. It is available as 2.5 mg tablets.

Frovatriptan has mean terminal elimination half-life of approximately 26 hours, which is substantially longer than other triptans.

Mechanism of Action
Frovatriptan is a 5HT receptor agonist, with high affinity for the 5-HT1B/1D receptors. It has no significant effects on the GABAA mediated channel activity and benzodiazepine binding sites.

Adverse Effects
Serious but rare cardiac events have been reported in patients with risk factors predictive of CAD. These include: coronary artery vasospams, transient myocardial ischemia, myocardial infarction, ventricular tachycardia and ventricular fibrillation.

Contraindications
Frovatriptan should not be given to patients with:
 * Ischemic Heart Disease
 * Cerebrovascular Syndrome
 * Peripheral Vascular Disease
 * Uncontrolled Hypertension
 * Hemiplegic or Basilar Migraine

US licensing
Frovatriptan is available only by prescription in the United States, and Canada where a secondary New Drug Approval (sNDA) was filed in July 2006, and which is currently pending. The FDA anticipates completing its review of this application on or before the current PDUFA (Prescription Drug User Fee Act) review date of August 19, 2007. If the sNDA is approved, Frova will be the only medication indicated in the U.S. for the short-term prevention of menstrual migraine (MM).