November 14 2012

Published in Parkinson's & Movement disorders

The Feinstein Institute for Medical Research announced today the submission of a NEW DRUG APPLICATION to the US Food and Drug Administration (FDA) for FLUORODOPA F 18 for PET scanning used to diagnose Parkinson's syndrome. Earlier this year, the Weinstein Institute received approval from the FDA under the expansion of the ACCESS INVESTIGATIVE NEW DRUG (IND) definition, which allows the Feinstein Institute to receive compensation for the use of diagnostic tools in a clinical trial. This was the first time that the FDA approved payment for PET trials of fluorodopa F 18 for parkinsonian symptoms.

Fluorodopa F 18 PET scan known as FDOPA PET SCAN is a simple but powerful scan, it is a non-invasive diagnostic tool, which allows early diagnosis and appropriate medical management of patients with symptoms of Parkinson's disease. Parkinsonian symptoms, such as decreased body movement, stiffness, tremors or trembling hands, are caused by Parkinson's disease or by various diseases such as Huntington's disease or the use of medications. It is important to separate parkinsonism from parkinsonism because the signs are the same, but non-parkinsonism patients will not respond to the drugs typical of parkinsonism. Many patients who do not have Parkinson's disease but show symptoms of Parkinson's disease receive unnecessary treatment, which has a possible harmful effect and does not improve the clinical signs over time. Parkinson's patients showed low levels of dopamine in the brain. The substance fluorodopa F 18, a sterile solution, is used in a PET scan to see the distribution of dopamine in the brain, so it may be possible to use it to diagnose Parkinson's patients and track the rate of progression of the disease. The Feinstein Institute has been using PET scanning with fluorodopa F 18 for about twenty years under the leadership of Dr. David Eidelberg, Dr. Thomas Challey, Dr. Vijay Dhawan. Under the leadership of Dr. Chali, the Feinstein Institute obtained the approval of the FDA for the expansion of IND (INVESTIGATIONAL NEW DRUG) access with payment and submission of an NDA (NEW DRUG APPLICATION) for the injection of Fluorodopa F 18. The Feinstein Institute is the first and only one to receive approval from the FDA To use the FDOPAPET scan under a program of expanding access to the IND, which allows Feinstein Institute researchers and its physicians to use this diagnostic tool in clinical trials and without compensation. "We submitted a full NDA for the FDOPAPET scan because we believe it will allow national recognition for an important diagnosis," said Dr. Chali. "The FDOPAPET scan, if approved, has a chance to improve the quality of life of patients with parkinsonian syndromes by saving unnecessary expenses and by the absence of side effects from treatment