FDA Grants Priority Review For MediQuest's Drug Application To Treat Raynaud's Disease

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Jun 2008 - 1:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

MediQuest Therapeutics Inc. announced that it has been granted priority review status from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for MQX-503, a topical formulation designed to treat Raynaud's Disease. A priority review provides the opportunity for an approvability decision by the FDA within six months instead of the standard ten months or more.

"Currently, there are no FDA-approved therapies for people with Raynaud's Disease," said Dr. Frederick Dechow, MediQuest president and CEO. "By granting a priority review of our therapy, the FDA has demonstrated its commitment to review in an expedited manner new treatments with the potential to meet unmet patient needs."

"Because the active agent used in MQX-503 has already undergone rigorous FDA review and has been approved in other drug products for use in patients with other diseases, its safety profile is well understood," said Dr. Jeff Gregory, Chief Medical Officer for MediQuest. "We are one step closer to bringing a new treatment option to the millions of people suffering from the symptoms of Raynaud's Disease."

Raynaud's patients seeking medical treatment, 90 percent of whom are women, can experience severe discomfort associated with chronic vasospasm episodes in their hands, feet and other extremities. MQX-503 is a locally acting, topical formulation that is designed to be applied to prevent or treat the symptoms associated with Raynaud's episodes, which would allow patients control over their disease.

In addition to MQX-503, MediQuest's product pipeline includes four other drug candidates, two in Phase II clinical studies, one at the pre-clinical stage and one at the research stage. The company develops first- and best-in-class topical therapies to treat patients suffering from inflammatory and infectious diseases.

About Raynaud's Disease

An estimated 9-11 million people in the United States suffer from Raynaud's Disease, 2.1 million of which have been diagnosed and are seeking medical treatment. Raynaud's patients can experience severe pain associated with chronic vasospasm episodes in their hands, feet and other extremities.

About MediQuest Therapeutics, Inc.

MediQuest Therapeutics is a specialty pharmaceutical company using its proprietary topical delivery system in late-stage clinical trials targeting infectious and inflammatory skin diseases and conditions. The Company's major efforts are focused on projects targeting Raynaud's phenomenon, nail psoriasis and actinic keratosis.

In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the 'Safe Harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's current expectation or forecasts of future events. MediQuest's performance and financial results could differ materially from those reflected in these forward-looking statements due to the decisions of regulatory authorities, ability to implement its commercial plans, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may affect the forward-looking statements please contact the Company. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. MediQuest undertakes no obligation to update publicly any forward-looking statement.

MediQuest Therapeutics, Inc.