среда, 6 апреля 2011 г.

New River Pharmaceuticals To Present Results From NRP104 Abuse Liability Studies

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 nrpharma .















"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.

nrpharma

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