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 treatment to be discovered, tested, approved, marketed, and then made available to you.
In an effort to speed up the process, the FDA is 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.
They 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-a treatment for oral mucositis caused by chemotherapy or radiation treatments in head and neck cancer patients.
In short, it's 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 40 percent of patients on chemo.
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.
TOPIC: FAST TRACK
REPORT: MB# 3669
FAST TRACK: The Fast Track programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. (SOURCE: http://newsroom.elan.com/phoenix)
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a Fast Track drug must show some advantage over available therapy, such as:
* Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes.
* Avoiding serious side effects of an available therapy.
* Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome.
* Decreasing a clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment.
A drug that receives Fast Track designation is eligible for some or all of the following:
* More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval.
* More frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers.
* Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.
* Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Céline McArthur at firstname.lastname@example.org.