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1/6/2003

New Triptan Approved as Migraine Therapy

Kate Traynor

Pfizer Inc.'s eletriptan hydrobromide product, Relpax, received marketing approval from the Food and Drug Administration (FDA) on Dec. 26, 2002, for the acute treatment of migraine.

According to Pfizer, clinical studies of eletriptan showed that it relieved pain, nausea, and sensitivity to light and sound in patients suffering from acute migraine.

Pfizer's announcement of the approval did not include an estimated date for the product's launch. The company's third-quarter 2002 financial report had predicted that FDA would approve the product by the end of 2002, with the launch to follow soon thereafter.

Relpax tablets will be available in three strengths: 20 mg, 40 mg, and 80 mg. But Pfizer said in a press release that the maximum recommended single dose of the product is 40 mg.

According to Pfizer, common adverse events associated with eletriptan use include fatigue, somnolence, nausea, and dizziness. The company noted that the common adverse events reported with eletriptan use are similar to those seen with other triptans.

Pfizer said patients with severe liver disease and people over age 65 or younger than 18 years should not use eletriptan.