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FDA Issues Second Approvable Letter for Trexima

August 2, 2007

GlaxoSmithKline (GSK) and Pozen announced that the FDA has issued a second approvable letter for Trexima.

In January, Pozen and GSK said they responded to the FDA’s first approvable letter, submitting additional safety data from clinical trials, data from GSK’s database and additional in vitro preclinical data.

According to the companies, in the second approvable letter, no additional information regarding the cardiovascular safety of Trexima  (sumatriptan/naproxen sodium) was requested.

The companies said they agreed to conduct a prospective study after approval to evaluate the effects on blood pressure during chronic, intermittent treatment.

The FDA has requested that Pozen further address the agency’s concern, prior to approval, about the potential implications from one preclinical in vitro chromosomal aberration study in which genotoxicity was seen for the combination of naproxen sodium and sumatriptan, but not with either component alone, the companies said.

None of the other three standard genotoxicity studies — Ames test, mouse lymphoma TK assay and in vivo mouse micronucleus assay — demonstrated any genotoxicity for the combination of naproxen sodium and sumatriptan, the companies added.