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WASHINGTON (Reuters Health) – The US Food and Drug Administration (FDA) has granted marketing approval to a longer-acting triptan for treating migraine in adults, Elan Corporation announced on Friday.
Dublin, Ireland-based Elan said it received FDA approval for frovatriptan succinate (Frova), a tablet for acute treatment of migraine with or without aura.
Frova, formerly referred to by the company as Frovelan, is a selective 5-hydroxytryptamine (5-HT) receptor agonist believed to inhibit the dilation of arteries associated with migraine attacks.
Elan licensed exclusive North American sales and distribution rights to the drug from UK-based Vernalis in 1998. With the FDA approval, Vernalis has earned a $15 million milestone payment. The company "expects to receive further performance-based milestones as well as royalties on Elan's sales of the product," it said on Friday. It has previously projected that its royalties could total as much as $30 million during the first 3 years of sales.
Frovatriptan has also been approved in France, which is serving as the reference member state for the EU. Menarini, which will market the drug in Europe under the brand name Migard, hopes for a launch in the first half of 2002.
Frova has a 26-hour half-life, Max Gershenoff, a spokesman for Elan, told Reuters Health. In contrast, currently marketed triptans have half-lives of 6 hours or less, he said, noting that migraine headaches usually last between 4 and 72 hours.
"It's obviously not the only advantage, but it is of key importance," Gershenoff said.
He said Elan will not release pricing information until the product launches because it is still in discussions with potential co-promotion partners. Elan plans to complete its launch plans before the end of this year, he noted.
The company intends to use its existing neurological products sales force to promote Frova, Gershenoff said. Elan has also said that it hopes to put in place a sizable detailing program aimed at general practitioners.
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