The Feinstein Institutes for Medical Research has received U.S. Food and Drug Administration (FDA) approval for a new Positron Emission Tomography (PET) drug to combat Parkinson’s disease. Fluorodopa F 18 Injection (NDA 200655) will help visualize dopaminergic nerve terminals in the striatum for the evaluation of patients with suspected Parkinsonian syndromes. Thomas Chaly, PhD, chief of Cyclotron/Radiochemistry at the Feinstein Institutes, was instrumental in this FDA approval.
A PET scan is an imaging test that helps to understand the disease condition of the organs at the cellular level. PET uses a short-lived radiopharmaceutical to visually observe the affected area of the organ. In patients with Parkinson’s disease who experience loss of dopaminergic neurons, FDOPA uptake will be lower and this reduced uptake can be visually observed in the PET scan.
As noted by Dr. Chaly, “This approval is the pinnacle of our venture to have a safe and effective imaging agent for the differential of Parkinsonian Syndromes.” He continued, “With this approval, PET centers across the United States can incorporate FDOPA F 18 into their diagnostic and treatment follow up programs for patients with Parkinson’s disease.”
Fluorodopa PET can be used to follow the disease’s progression. Additionally, for Parkinson’s disease patients who have received intracerebral transplantation of adrenal medulla tissue or fetal mesencephalic tissue, FDOPA PET may help to study the integrity and activity of the implant.
Fluorodopa F 18 Injection is injected into a vein (intravenous) in preparation for an imaging test (PET Scan) to help detect the damaged or lost dopaminergic nerve cells. It is used in addition to other tests for diagnosing Parkinsonian Syndromes. See the link for full FDA description. The Feinstein Institute for Medical Research first submitted a New Drug Application for this technology back in 2012.
Who is Feinstein Institute for Medical Research?
Based in Manhasset, NY, Feinstein Institute for Medical Research is home to an international scientific leaders in many areas, including Parkinson’s disease, Alzheimer’s disease, psychiatric disorders, rheumatoid arthritis, lupus, sepsis, human genetics, Alzheimer’s disease, psychiatric disorders, rheumatoid arthritis, lupus, sepsis, human genetics, pulmonary hypertension, and more.
Functioning as the research arm of Northwell Health, they are home to 50 research labs, 2,500 clinical research studies, and 4,000 professional and support staff. Feinstein researchers have made breakthroughs in molecular medicine, genetics, cancer, brain research, mental health, autoimmunity and bioelectric medicine, among others, and continue work in those and other areas. They are a laboratory and faculty home of the Elemzzi Graduate School of Molecular Medicine. Additionally, students without an MD degree can earn a PhD in molecular medicine via the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell as part of the medical school’s MD/PhD or PhD programs. Its current name derives from a financial donor—Leonard Feinstein, co-founder of Bed Bath & Beyond who made a $25 million gift. The Feinstein’s have made at least $50 million in donations.
By 2019, they were comprised of 5 institutes:
· Institute of Bioelectronic Medicine, led by Yousef Al-Abed, PhD
· Institute of Molecular Medicine, led by Betty Diamond, MD
· Institute of Cancer Research, led by Richard R. Barakat, MD
· Institute of Health Innovations & Outcomes Research, led by Thomas McGinn, MD MPH
· Institute of Behavioral Science, led by John Kane, MD
Thomas Chaly, PhD, chief of Cyclotron/Radiochemistry at the Feinstein Institutes