Raynaud's Disease - MediQuest Receives NDA Response From FDA

Main Category: Cardiovascular / Cardiology
Also Included In: Women's Health / Gynecology;  Regulatory Affairs / Drug Approvals
Article Date: 02 Nov 2008 - 0:00 PDT

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

MediQuest Therapeutics, Inc. received a Complete Response letter from the U.S. Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products for its New Drug Application (NDA) 22-241 (covering Vascana® [MQX-503], a proposed topical therapy for Raynaud's Disease). The application received priority review and the letter was received one day prior to the six-month PDUFA date of Oct. 25, 2008.

FDA indicated that the NDA could not be approved in its present form. The FDA identified issues that must be addressed by MediQuest before final marketing approval will be granted for Vascana. MediQuest will discuss these issues with the FDA and will provide an update when appropriate.

About Vascana

Vascana is a topical therapy indicated for the treatment of symptoms associated with Raynaud's Disease. Raynaud's patients, 90 percent of whom are women, can experience severe pain associated with chronic vasospasm episodes in their hands, feet and other extremities. Vascana 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. An estimated 9-11 million people in the United States suffer from Raynaud's, 2.1 million of whom have been diagnosed and are seeking medical treatment. No drugs have been approved by the FDA for the treatment of Raynaud's.

About MediQuest

MediQuest Therapeutics is a specialty pharmaceutical company using its proprietary topical delivery system targeting infectious and inflammatory skin diseases and conditions. The Company's major efforts are focused on projects targeting Raynaud's Disease, nail psoriasis and actinic keratosis. www.mqti.com.

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.