On the fast track

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Posted: Wednesday, September 18, 2013 4:11 pm

ORLANDO, Fla. (Ivanhoe Newswire) --For people suffering from debilitating diseases and disorders, new treatments can’t come fast enough. We all know that it could take many years for a new drug or device to be discovered, tested, approved, marketed and then made available to you. In an effort to speed up the process, the FDA says it’s fast tracking promising drugs and breakthrough therapies for serious and life-threatening conditions.

Researchers are on the fast track to develop a treatment designed to reduce neuropsychiatric symptoms—or NPS—in patients with moderate to severe Alzheimer’s disease.

Those symptoms are agitation and aggression. Researchers say 99-percent of the 5.4 million Americans with AD will develop them. The clinical trial will run 12 weeks and include 400 patients nationwide.

Researchers also got the green light to develop a treatment that could prevent post-surgical chronic pain. The strategy—a single dose injection of AYX1 given before surgery. Ninety patients undergoing knee replacement surgery will take part in the phase two study.

Another potential breakthrough in the fast lane– a treatment for oral mucositis caused by chemotherapy or radiation treatments in head and neck cancer patients. In short, oral mucositis is tissue swelling that can cause mouth pain, sores, bleeding and infection; making cancer treatments harder to handle and ultimately less effective. 90-thousand cancer patients in the United States and 40-percent of patients on chemotherapy are impacted by oral mucositis every year. A phase two multi-center, double-blind study will be launched before the end of the year.

The fast-track status expedites the review of new drugs intended to serve unmet medical needs in serious or life-threatening conditions and may shorten the time to FDA approval.

To learn more about the program, go to: http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm122932.htm

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