Feinstein announces submission of new drug application for diagnosing parkinsonian syndromes

November 14, 2012

The Feinstein Institute for Medical Research announced today the submission of a New Drug Application to the US Food and Drug Administration (FDA) for the Fluorodopa F 18 positron emission tomography (PET) scan used to diagnose parkinsonian syndromes. Earlier this year, the Feinstein Institute received FDA approval under an Expanded Access Investigational New Drug (IND) program, permitting the Feinstein Institute to receive reimbursement for the use of the diagnostic tool in clinical research studies. This was the first time the FDA approved payment for Fluorodopa F 18 PET studies in parkinsonian syndromes.

The Fluorodopa F 18 PET scan, also known as FDOPA PET scan, is a simple yet powerful, noninvasive that allows for the early diagnosis and proper medical management of patients with symptoms of Parkinson's disease. Parkinsonian syndromes, such as decreased , stiffness or rigidity, tremors or shaking of hands, are either caused by Parkinson's disease or by some other medical conditions, including Huntington's disease or drug use. It is important to differentiate if a patient has parkinsonian syndromes or Parkinson's disease because the symptoms are identical, but non-Parkinson's disease patients will not respond to typical Parkinson's disease medications. Many patients who do not have Parkinson's disease but do have parkinsonian syndromes endure unnecessary, potentially harmful treatment that ultimately doesn't alleviate their symptoms long term.

Patients with Parkinson's disease have demonstrated a low level of the in the brain. The drug Fluorodopa F 18, a sterile solution, is used with PET to visualize the distribution of dopamine in the brain, and therefore may be used to confirm the diagnosis of Parkinson's disease and to follow the rate of disease progression.

The Feinstein Institute has been using Fluorodopa F 18 PET scan for the last 20 years under the leadership of David Eidelberg, MD, Thomas Chaly, PhD, and Vijay Dhawan, PhD. It is under the leadership of Dr. Chaly that the Feinstein Institute achieved the of the Expanded Access IND with payment and the submission of a NDA for Fluorodopa F 18 Injection. The Feinstein Institute is the first and only research institute to receive approval from the FDA to use FDOPA PET scan under an Expanded Access IND program, allowing Feinstein Institute researchers and doctors to use the diagnostic tool in clinical research studies and receive reimbursement.

"We submitted a full New Drug Application for FDOPA PET scan, as we believe this will provide national recognition for an important diagnostic," said Dr. Chaly. "The FDOPA PET scan, if approved, has the potential to improve the quality of life for patients with parkinsonian symptoms by thwarting unnecessary costs and side effects from treatments."

Related Stories

FDA approval for Siemens PET Scan - MRI combo

June 13, 2011

(Medical Xpress) -- The Siemens Biograph mMR system, offering both a PET scan and an MRI that work simultaneously, has been given approval by the FDA. The idea behind this machine and the ability to run both tests at the ...

FDA panel unanimously votes down Parkinson's drug

October 17, 2011

A panel of federal medical specialists has unanimously voted that a drug for Parkinson's disease from Teva Pharmaceuticals has not been shown to slow progress of the debilitating neurological disease.

New imaging test aids Alzheimer's diagnosis

August 23, 2012

In research studies, scientists regularly use positron emission tomography (PET) scans to detect signs of Alzheimer's disease. Now, Washington University physicians at Barnes-Jewish Hospital are the first in Missouri to offer ...

Recommended for you

Tackling Parkinson's with targeted therapeutic vaccines

December 24, 2014

Clinical trials are about to begin on a new Parkinson's disease vaccine that could offer patients significant improvements over current treatments. The vaccine, developed through the FP7-funded SYMPATH project, may actually ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.