MediQuest, Crawling Out of the Bunker, Eagerly Awaits Results From Pivotal Raynaud’s Study

6/16/10Follow @xconomy

MediQuest Pharmaceuticals has barely made a peep since the FDA declined to approve its drug for Raynaud’s disease back in October 2008. But now the Bothell, WA-based company is starting to poke its head up again as it takes another shot at getting its first drug cleared for sale in the U.S.

This week, MediQuest said it has finished screening 284 patients into a clinical trial for Raynaud’s, a condition of limited blood circulation that causes pain and numbness in the fingers and toes in cold temperatures. That means MediQuest should have some fresh clinical trial results on the effectiveness of its gel treatment by August, and, if they are positive, be able to file an updated application to the FDA before the end of the year.

MediQuest was hopeful once before that it would win FDA approval. The drug, MQX-503 (Vascana), is a squeeze-on gel designed to improve blood circulation in the hands and feet. There’s nothing currently approved by the FDA for treating Raynaud’s, and while most of the time it’s considered a minor annoyance that doesn’t require medical treatment, an estimated 2.1 million people in the U.S. are considered candidates for therapy, MediQuest says. Since nobody had ever tried to win regulatory clearance to treat Raynaud’s before, there are no precedents to follow, and the path forward after the rejection took several months to figure out in talks with the FDA. Now, MediQuest says it has the clarity it needs from regulators, and success will hinge on whether its clinical trial is positive.

“We had some logistical hurdles we had to overcome first,” Dechow says.

MediQuest’s original application to the FDA didn’t pass muster because of what Dechow called “intrasubject variation.” Even while the trial reached its main goal of reducing pain and numbness, each patient saw their benefits fluctuate based on variables like how cold the weather was on a certain day. To really confirm that the MediQuest drug was offering a benefit, the FDA proposed a different kind of study. This time, patients would go into a consistent, controlled environment—a cold room, sort of like a meat locker, kept at 40 degrees Fahrenheit.

That might sound great as an experimental design, to see whether the drug relieves pain in a consistent setting, but it wasn’t easy for MediQuest to execute. Each of the 12 clinical trial sites that MediQuest enlisted for this study needed to get approval from the local Institutional Review Board (IRB), which is charged with protecting patient safety. Some objections were raised that such a study would knowingly subject patients to pain, given that some patients would get the drug while others were randomly assigned to a placebo. Plus, since such a study had never been done before, MediQuest needed to make sure a proper “cold room” existed at each of the clinical trial sites, without any noxious chemicals or biological tissues that might introduce new variables into the experiment, Dechow says.

It was late spring of 2009 before the company and the FDA were on the same page … Next Page »

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