New River Pharmaceuticals Inc. (Nasdaq: NRPH) announced today that it anticipates that results will be presented from its three clinical abuse liability studies on NRP104, a compound being developed as a treatment for attention-deficit/hyperactivity disorder (ADHD).
Dr. Donald Jasinski, Professor of Medicine, Chief Center for Chemical Dependence, Johns Hopkins Bayview Medical Center, the principal investigator for the three clinical abuse liability studies, is expected to present results from the studies in two separate presentations at the annual meeting of the College on Problems of Drug Dependence (CPDD) in Scottsdale, Arizona.
Data from the A01 study and the top line data on the A03 study will be presented at an oral presentation scheduled to begin Sunday, June 18 at 1:45 pm. MST. The A01 presentation, Pharmacokinetics of oral NRP104 (lisdexamfetamine dimesylate) versus d-amphetamine in healthy adults with a history of stimulant abuse, will discuss the pharmacokinetic effects of NRP104 in stimulant abusers. The A03 study, Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse, evaluated the likeability of NRP104 compared to positive controls and placebo in stimulant abusers. Data from the A02 study, Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories, will be presented at a poster session scheduled to begin at 1:30 p.m. MST on Tuesday, June 20.
Data from the three studies have been submitted to the FDA as part of the new drug application for NRP104 as a treatment for pediatric ADHD. The company anticipates that these data, along with all the other clinical and non-clinical abuse liability studies conducted by New River, will help inform the FDA and the U.S. Drug Enforcement Agency in assigning an appropriate controlled substance schedule to NRP104. NRP104 has not been scheduled for its use during clinical trials, although the DEA is expected to assign a schedule before the drug is made available for commercial sale.
Under review by the U.S. Food and Drug Administration as a potential treatment for pediatric ADHD, NRP104 is the subject of a collaboration agreement between New River and Shire plc (LSE: SHP; Nasdaq: SHPGY; TSX: SHQ).
New River and Dr. Jasinski plan to organize a conference call several business days following the presentations at CPDD to elaborate upon the studies and their results. Details regarding the conference call will be provided in a later press release.
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