NRPH news yesterday:
New River Pharmaceuticals` NRP104 Receives FDA Fast Track Designation for Treatment of Cocaine Dependence
August 31, 2004 14:23:00 (ET)
RADFORD, Va., Aug 31, 2004 /PRNewswire-FirstCall via COMTEX/ -- New River Pharmaceuticals Inc. (NRPH, Trade) announced today that it has received notice from the U. S. Food and Drug Administration (FDA) that its Investigational New Drug (IND), NRP104, has been designated as a fast track product for treatment of cocaine dependence.
"We are pleased that NRP104 has been granted fast track designation for the treatment of cocaine dependence and currently are collaborating with officials at the National Institute on Drug Abuse (NIDA) to design appropriate preclinical and clinical programs in connection with this IND," said Suma Krishnan, Vice President, Product Development for New River Pharmaceuticals. This is New River Pharmaceuticals' second IND for NRP104. The company continues its clinical investigation of this drug for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric populations, although it does not have fast track designation for that indication.
"We believe that because of NRP104's pharmacodynamics and its potential abuse-resistant and overdose-protective properties, the drug could possess promise as a viable agonist therapy for cocaine dependence," said Rob Oberlender, PhD, Director of Drug Abuse Science & Communications at New River Pharmaceuticals.
Under Section 506 of the Federal Food, Drug, and Cosmetic Act, the FDA has authority to grant fast track designation to expedite drug development and review of a product where no available therapies exist to treat serious and life-threatening conditions. Fast track designation does not guarantee approval or expedited approval of any application for a product.
New River Pharmaceuticals is a specialty pharmaceutical company focused on developing novel pharmaceuticals that are safer and improved versions of widely-prescribed drugs, including amphetamines and opioids.
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