Current Report — Form 8-K Filing Table of Contents
Document/ExhibitDescriptionPagesSize 1: 8-K New River Pharmaceutical 8-K 6-20-2006 HTML 27K
2: EX-99.1 Miscellaneous Exhibit HTML 83K
3: EX-99.2 Miscellaneous Exhibit HTML 16K
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Section
8 — Other Events
Item
8.01.
Other
Events.
On
June20, 2006, Dr. Donald Jasinski, Professor of Medicine, Chief Center for Chemical
Dependence, Johns Hopkins Bayview Medical Center, presented data from the A02
clinical abuse liability study on NRP104 at the annual meeting of the College
on
Problems of Drug Dependence in Scottsdale, Arizona. NRP104 is the
subject of a new drug application filed by New River Pharmaceuticals Inc. (the
“Company”) with the U.S. Food and Drug Administration on December 6, 2005,
seeking approval for three therapeutic doses (30, 50 and 70 mg) of NRP104 for
the treatment of attention-deficit/ hyperactivity disorder (ADHD) in pediatric
populations. This
poster presentation is attached hereto as Exhibit 99.1 and incorporated
herein by reference. The Company issued a press release on June 20, 2006 with
respect to this presentation, which press release is attached hereto as Exhibit
99.2 and incorporated herein by reference.
The
A02
study was a double-blind, placebo- and active-controlled, single-dose crossover
pharmacodynamic and pharmacokinetic study to evaluate the safety, tolerability
and abuse liability of intravenously administered NRP104 in healthy adult
volunteers with histories of stimulant abuse.
On
a mole
weight basis, the amphetamine free base content in NRP104 50 mg is equivalent
to
the amphetamine free base content of 20 mg of d-amphetamine
sulphate, a Schedule II stimulant. Given intravenously, d-amphetamine
sulfate 20 mg produced significant responses on the measures of amphetamine-like
effects that peaked within 15 minutes of administration. These included
significant euphoric responses (Liking scales and Morphine-Benzedine Group
scales) and amphetamine-like subjective effects (Amphetamine scales and
Benzedrine Group scales). Under the same conditions, NRP104 50 mg did not
produce euphoria or amphetamine-like subjective effects, as evidenced by the
lack of significant responses on these same scales. The
company believes that this indicates that lisdexamfetamine dimesylate 50 mg
given intravenously is significantly less reinforcing than d-amphetamine
20 mg given intravenously.
Even
though they contain equal amounts of d-amphetamine
base, in the Treatment Enjoyment Assessment Questionnaire administered at the
end of the study, eight out of nine (89%) of the study subjects stated that
they
would not take lisdexamfetamine dimesylate 50 mg again, while six out of nine
(67%) of the study subjects stated that they would take 20mg d-amphetamine
again. These results indicate that NRP104 appeared to have little likelihood
for
abuse by the intravenous route. NRP104 doses were safe and well-tolerated
in the population of stimulant abusers.
2
Section
9 — Financial Statements and Exhibits
Item
9.01.
Financial
Statements and Exhibits.
(c)
Exhibits.
99.1
Poster
presentation made on June 20, 2006 by Dr. Donald Jasinski at the
annual
meeting of the College on Problems of Drug
Dependence.
99.2
Press
release issued on June 20, 2006 by the
Company.
3
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
