Pozen Pounded on FDA's Trexima Delay

Imitrex and related product sales totaled $1.4 billion in 2006, but the blockbuster migraine drug franchise has begun to lose patent protection.

Pozen filed Trexima for approval with the FDA in August 2005. In June 2006, the agency issued an approvable letter, requesting additional safety data on the drug before it could be approved.

Now, the FDA has issued a second approvable letter on Trexima, requesting yet more safety data.

The issue this time, according to Pozen, is a preclinical (nonhuman) test that revealed chromosomal or gene damage for the combination of Imitrex and naproxen, the two components of Trexima. Three other so-called genotoxicity tests were OK, the company said, but the negative safety signal from the single test was enough to cause the FDA to hold up Trexima's approval.

On a conference call Thursday, Pozen CEO John Plachetka tried to reassure investors that this issue was relatively minor and could be handled expeditiously. But in the best-case scenario, Plachetka said it would take two or three months for the company to conduct a new genotoxicity test and resubmit the data to the FDA.

When pressed, the CEO acknowledged that the company has not yet spoken with the FDA, and he's not entirely sure how long the process will take. Given Pozen's track record with regulatory matters and drug approvals, Plachetka's assurances ring hollow.

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