Skip to main content

Pozen Frozen on FDA Data Request

Shares slide 13%.

Shares of drugmaker



sank Wednesday after regulators said that further data must be submitted before the company's experimental migraine drug Trexima can be approved for marketing.

Scroll to Continue

TheStreet Recommends

Shares were down $1.84, or 10.2%, to $16.27.

After reviewing the company's initial application early this year, the Food and Drug Administration requested additional information on the drug, a combination of the pain relievers sumatriptan and naproxen sodium, through a so-called approvable letter, in June.

The company responded to the agency's request in November, but regulators are saying the reply is still incomplete. Pozen expects to submit additional data, which are required to fully assess the drug's safety, before the end of the year.

"We appreciate this additional guidance from the FDA with respect to the information to be included in our complete response," said Dr. Marshall Reese, Pozen's executive vice president of product development. "Although there is no certainty that these revisions, coupled with the original data, will lead to the approval of the Trexima

new drug application, we continue to believe that the data for Trexima demonstrate superior efficacy and a safety profile comparable to sumatriptan."