POZEN Swiftly Responds To FDA Approvable Letter for Migraine Treatment Trexima!

Again Pozen Resubmits A Response To FDA Approvable Letter for Trexima™

WASHINGTON, DC October 15th, 2007—POZEN announced today that it submitted a response to the FDA Approvable Letter for Trexima received on August 1, 2007. This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss the proposed plan for responding to the Approvable Letter.

POZEN believes the submission constitutes a complete response. The submission includes, in addition to a required routine Safety Update and revised product labeling, the results of three non-clinical (in vitro) studies that provide clarifying information about a previously submitted non-clinical study, the Chinese Hamster Ovary (CHO) essay. The FDA may take up to six months to review this submission, although the company has requested a 60-day review.

In addition, while the non-clinical data are under review by the FDA, POZEN plans to conduct a clinical evaluation of the genotoxic potential of Trexima in a short-term study in human volunteers in the event the FDA requires this data. This study is expected to begin this quarter with results available for submission to and review by the FDA, if required, during the first quarter of 2008.

“Although we believe that our submission addresses FDA’s concern regarding the genotoxic potential of Trexima, we feel it is prudent to conduct this clinical trial so that we can provide this information without delay, if required,” said Dr. Marshall Reese, executive vice president, product development.

When we first reported on this back on August 4th, this past summer we had many an upset Migraineurs looking to see a new treatment available soon, considering this drug is a compound of two existing safe FDA approved drugs.  In response to our summer article, one of MAGNUM’s medical advisors wrote in to address this anominaly.  According to the respected leading Migraine medical researcher Dr. Alexander Mauskop, of the New York Headache Center—

“The reason for the negative headlines on Trexima is mostly because patent for Imitrex expires in 2009 and GSK was hoping to replace sales of Imitrex with Trexima before generic Imitrex floods the market. The delays make it more difficult for the company to convince doctors to switch to Trexima before the generic Imitrex becomes available. Once the generic Imitrex is on the market many HMOs may insist on patients taking a generic Imitrex and a generic naproxen instead of Trexima. So the negative outlook is not from patients' or doctors' point of view, but from the business community's point of view.”

For more Migraine news stay tuned to the HealthCentral Network!

POZEN will have a Webcast about this today & for replay:
POZEN will hold a webcast to provide an update on Monday, October 15, 2007 at 11:00 a.m. Eastern time. The webcast can be accessed live and will be available for replay at www.pozen.com.