Pozen is preparing another bid to win approval for its proposed migraine drug Trexima.
The pharmaceutical firm said Friday morning that it and partner GlaxoSmithKline would file additional information with the Food and Drug Administration “within the next ten days.”
In August, Pozen (Nasdaq: ) shares plunged 46 percent after the FDA declined to approve Trexima and asked for additional information.
The “approvable letter” as it is called from the FDA is the second one issued about Trexima. Pozen and GSK responded to the first letter with additional data in January.
The latest letter expressed concerns about genotoxicity, or damage to DNA, that was “seen for the combination of naproxen sodium and sumatriptan,” Pozen said in a statement in a letter in August. Those are the ingredients Pozen has combined in one pill. The genotoxicity was observed in one of four studies, Pozen said.
On Friday, Pozen said it and GSK had met with the FDA about how to respond to the FDA request.
“POZEN believes the submission will constitute a full response,” the company said. “The submission will include clarifying non-clinical information to further address the agency’s concern regarding the genotoxic potential of Trexima and, as required by FDA, a routine clinical safety update.”
Further FDA review could take up to six months, but Pozen said it would request an “expedited review.”
The FDA may take up to six months to review this submission, although POZEN will request an expedited review.
In an earlier review of the drug the FDA expressed concern about cardiovascular side effects.
Pozen used its proprietary technology to combine an existing GSK migraine drug Imitrex with naproxen, a non-sterodial anti-inflammatory drug.
According to the American Medical Association, migraines affect an estimated 28 million people.
GSK has paid Pozen more than $35 million to develop Trexima.
