Second approvable letter for GSK and Pozen migraine treatment

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The FDA delivered a further setback to GlaxoSmithKline and Pozen's developmental migraine treatment Trexima yesterday in the form of a second approvable letter seeking more data related to the drug.

Both companies said the FDA asked Pozen to address potential implications from a preclinical study into chromosomal risks in which genotoxicity was seen for the combination of naproxen sodium and sumatriptan, but not with either component alone.

Trexima combines GSK's migraine drug Imitrex (sumatriptan) with the generic anti-inflammatory, naproxen sodium.

The companies said they plan to request a meeting with the FDA as quickly as possible to discuss necessary steps to address the agency's concerns.

In June 2006, the FDA also issued an approvable letter on Trexima that asked for additional drug safety information. The FDA did not accept the drugmakers' additional data submitted by the company in November. The companies then filed additional safety data in January.

Imitrex currently holds around 56% of the migraine drug market and brought in $1.1 billion in sales for GlaxoSmithKline in 2005. With Trexima, GSK and Pozen hope to replace Imitrex as the top migraine treatment when the drug's patent expires in 2009.

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