(09/05/13) - Marketed as miracle treatments for the worst diseases, some
treatments seem to fly through the FDA's screening process more quickly than
New treatments can't come along quickly enough for some people suffering with debilitating or deadly diseases.
It can take years for new drugs to gain approval, but in an effort to speed up the process, the FDA is fast-tracking what it deems to be some of the more promising breakthroughs. That includes three drugs on the fast track to approval right now.
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.
Researchers also get 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.
Another potential breakthrough in the fast lane is a treatment for oral mucositis, caused by chemotherapy or radiation treatments in head and neck cancer patients. In short, the condition is tissue swelling that can cause mouth pain, sores, bleeding, and infection, making cancer treatments harder to handle and ultimately less effective. Oral mucositis impacts about 90,000 cancer patients in the U.S. every year and nearly half of chemo patients.
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.
ABC12 Main Station