New River Pharmaceuticals To Present Results From NRP104 Abuse Liability Studies

Main Category: ADHD
Also Included In: Clinical Trials / Drug Trials;  Pediatrics / Children's Health
Article Date: 15 Jun 2006 - 0:00 PDT

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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.

About New River

New River Pharmaceuticals Inc. is a specialty pharmaceutical company developing novel pharmaceuticals that are generational improvements of widely prescribed drugs in large and growing markets.

For further information on New River, please visit the company's website at http://www.nrpharma.com .

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM

ACT OF 1995

This press release contains certain forward-looking information that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995. Forward- looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, financial projections and estimates and their underlying assumptions; statements regarding plans, objectives and expectations with respect to future operations, products and services; and statements regarding future performance. Such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of New River Pharmaceuticals, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include: those discussed and identified in the New River Pharmaceuticals Inc. annual report on Form 10-K, filed with the SEC on March 15, 2006; the timing, progress and likelihood of success of our product research and development programs; the timing and status of our preclinical and clinical development of potential drugs; the likelihood of success of our drug products in clinical trials and the regulatory approval process; our drug products' efficacy, abuse and tamper resistance, onset and duration of drug action, ability to provide protection from overdose, ability to improve patients' symptoms, incidence of adverse events, ability to reduce opioid tolerance, ability to reduce therapeutic variability, and ability to reduce the risks associated with certain therapies; the ability to develop, manufacture, launch and market our drug products; our projections for future revenues, profitability and ability to achieve certain sales targets; our estimates regarding our capital requirements and our needs for additional financing; the likelihood of obtaining favorable scheduling and labeling of our drug products; the likelihood of regulatory approval under the Federal Food, Drug, and Cosmetic Act without having to conduct long and costly trials to generate all of the data which are often required in connection with a traditional new chemical entity; our ability to develop safer and improved versions of widely prescribed drugs using our Carrierwave (TM) technology; and our ability to obtain favorable patent claims. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. New River Pharmaceuticals does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in New River Pharmaceuticals' annual report on Form 10-K, filed with the SEC on March 15, 2006, as well as other public filings with the SEC.

New River Pharmaceuticals Inc.
http://www.nrpharma.com

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