Navigation Links
Feinstein announces submission of new drug application for diagnosing parkinsonian syndromes
Date:11/14/2012

MANHASSET, NY 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 diagnostic tool that allows for the early diagnosis and proper medical management of patients with symptoms of Parkinson's disease. Parkinsonian syndromes, such as decreased body movements, 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 neurotransmitter dopamine 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 FDA approval 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."


'/>"/>

Contact: Emily Ng
eng3@nshs.edu
516-562-2670
North Shore-Long Island Jewish (LIJ) Health System
Source:Eurekalert

Related medicine news :

1. Feinstein Institute to receive grant to improve schizophrenia treatment
2. Feinstein Institute to Receive Grant from Centers for Medicare & Medicaid Services to Improve Schizophrenia Treatment
3. Feinstein Institute researchers discover that bean used in Chinese food could protect against sepsis
4. AFAR announces the 2012 Hartford Centers of Excellence in Geriatric Medicine awards
5. Bascom Palmer Eye Institute announces breakthrough for degenerative vision disorder
6. University of Houston Graduate College of Social Work announces partnership with MD Anderson
7. The Ludwig Institute for Cancer Research announces launch of iTeos Therapeutics SA
8. AGA announces prestigious awards recognition recipients
9. TheBestHeartRateMonitorReviews.com Announces The Top 3 Heart Rate Monitors
10. Article Marketing Company Content Writing King Announces Training Of New Graphic Design Artist
11. Zane Benefits Announces Wellness HRAs: A New Way to Reward Healthy Employees
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 2017 , ... Many families have long-term insurance that covers care for a ... waiver for care if the client has a cognitive impairment diagnosis. , “What ... is often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented ... the lowdown on sciatica in a new episode of "Success Files," which is ... events and innovation and investigates each subject in-depth with passion and integrity. , ...
(Date:10/12/2017)... ... 12, 2017 , ... CitiDent and San Francisco dentists, Dr. ... Oventus O2Vent technology. As many as 18 million Americans are estimated to suffer ... Oral appliances can offer significant relief to about 75 percent of people with ...
(Date:10/12/2017)... ... , ... Asante, a nationally recognized health system in southern ... home health joint venture through an agreement, effective October 1, 2017, to create ... health company with Asante, delivering clinically integrated care, for the past eight years. ...
(Date:10/12/2017)... Wesley Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... Chapel is holding a treadmill relay – Miles by Moonlight to raise money for ... by donating $300 or more. , Teams will work together to keep their ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... PROVIDENCE, R.I. , Sept. 25, 2017 /PRNewswire/ ... immunogenicity assessment, vaccine design, and immune-engineering today announced ... focused on the development of personalized therapeutic cancer ... and has provided exclusive access to enabling technologies ... MSc Eng., MBA will lead EpiVax Oncology as ...
(Date:9/22/2017)... , Sept. 22, 2017  As the latest Obamacare ... Bill Cassidy (R-LA) and Lindsey Graham ... that the medical device industry is in an odd ... tax, the 2.3% excise tax on medical device sales ... also want covered patients, increased visits and hospital customers ...
(Date:9/19/2017)... medical device company developing a non-invasive, robotically assisted, platform therapy that uses pulsed sound energy ... ... Jim Bertolina, PhD ... Tom Tefft ... executive Josh Stopek , PhD, who has led R&D and business development teams at ...
Breaking Medicine Technology: