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New River Pharmaceuticals Inc. Initiates Pivotal Phase III Trial Of NRP104 For Adult ADHD

Published: May 23, 2006

RADFORD, Va., May 23 /PRNewswire-FirstCall/ -- New River Pharmaceuticals Inc. announced today that screening has begun in a pivotal Phase III clinical trial for NRP104 for the treatment of attention deficit hyperactivity disorder (ADHD) in adult populations (ages 18 - 55). The outcome of this trial is anticipated to support a supplemental new drug application ("sNDA"), which the company hopes to file with the United States Food & Drug Administration in the second quarter of 2007.

Company officials conducted a meeting in early May with clinical investigators participating in the study. "It was an upbeat and a positive meeting," remarked Suma Krishnan, New River's Vice President, Product Development. "We are pleased to begin screening on the clinical investigation of NRP104 as a potential treatment to address adult ADHD." Market data estimates that 8.5 million adults in the United States suffer from ADHD, and that 75% of these people remain undiagnosed, under-treated or untreated.

NRP104 is the subject of a collaborative development and commercialization agreement between New River and Shire plc .

On December 6, 2005, New River submitted to the FDA a new drug application seeking approval to manufacture and market NRP104 for the treatment of ADHD in pediatric populations (ages 6 - 12). The Prescription Drug User Fee Act (PDUFA) date-the date by which the FDA is expected to review and act on this NDA submission for NRP104-is October 6, 2006. New River and Shire hope to launch NRP104 as a treatment for pediatric ADHD by January 2007.

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 more information on New River, please visit the company's web site 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.

Contacts: The Ruth Group John Quirk (investors) 646-536-7029 jquirk@theruthgroup.com Zack Kubow (media) 646-536-7020 zkubow@theruthgroup.com

New River Pharmaceuticals Inc.

CONTACT: John Quirk, investors, +1-646-536-7029, jquirk@theruthgroup.com,or Zack Kubow, media, +1-646-536-7020, zkubow@theruthgroup.com, both of TheRuth Group for New River Pharmaceuticals Inc.

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