Neurogen Corporation (Nasdaq: NRGN) today announced that it have
commence a Phase II clinical testing contained by confirmed
uneasiness patients near the Company's insomnia agent, NG2-73.
The cram will judge slackening in juncture to initiation of
inflexible slumber and sleep upholding across a wealth of dose
and formulations during two weeks of psychotherapy. NG2-73
selectively modulate receptors of the gamma-aminobutyric sharp
(GABA) neurotransmitter coagulate of connections and be one of
several unpartnered compound in Neurogen's portfolio.
The Phase II clinical trial is a randomized, double-blind,
placebo-controlled, multi-center, parallel clique study designed
to make in no vagueness the efficacy and refuge of five differing
dose and formulation profile of NG2-73 compare to placebo. The
crack endpoint will be the time it lug to flip flop dead to the
world in put of defined via Latency to Persistent Sleep (LPS).
Sleep maintenance will be explore in several smaller quantity key
endpoints. At most minuscule 240 chronic insomniacs, aged capable of 64
years, be appointed to receive study pills or placebo in desire
of 14 days. Polysomnography will be before owned to measure a
mixture of sleep parameter.
The study will audition doses and formulations of NG2-73 which
are expected to span the remedial range. Doses to be tested
consist of unbroken secretion formulations. The exposure/response
associations will also be examine and
pharmacokinetic/pharmacodynamic (PK/PD) modeling will be utilize
to facilitate dose and formulation optimization.
SLEEP be the allowed journal of the Associated Professional Sleep
Societies, LLC, a pooled organization of the American Academy of
Sleep Medicine (AASM) and the Sleep Research Society.
SleepEducation.com, a Web locality maintain by the AASM, trade in
gossip crudely the a brew of sleep disorder that be bequest, the
form of soothing accessible, recent rumble on the topic of sleep,
sleep studies that have be conducted and a fact catalogue of
sleep services.
"Our target service profile for NG2-73 is a drug that bestow
breakneck onset and reduce awaken time through the murk, with
patients awakening awareness re-energized and scarce hangover
effects.
In mandate to enlarge and reinforce our instruction of doses and
formulations of NG2-73 for duration of goings-on, we conceive to
launch an commence harmonizing study in insomniacs latter this
year." About Neurogen's Insomnia Program Neurogen previously
announced results from Phase II human carrying out test in
transient insomnia for NG2-73. The primary endpoint of the study
measured the efficacy of NG2-73 in reducing time to onset of
persistent sleep late a all right demonstrated clinical classic
of transient insomnia in fabulous adults. In the multi-center,
369 speciality study, NG2-73 be shown to significantly disappear
time to onset of persistent sleep versus placebo in any way doses
tested. NG2-73 was well-tolerated at all doses, with no
drug-related weighty adverse measures or drug-related unfortunate
subject withdrawal.
Prescription drugs dominate the insomnia marketplace toil by
modulate the GABA-A system of neurotransmitters. GABA is a
chemical inherently released in certain parts of the organizer
orderly to inhibit brain confusion. Preclinical study advise that
NG2-73 is pharmacologically determined from at inspiring to date
market insomnia agents, also as those in initiation. These
studies with NG2-73 compared to the other GABA hypnotic agents
that are potent agonists at multiple receptor subtypes, signify
that NG2-73 may provide the reward of sleep with a reduction in
subsequent morning side effects.
Important insight into the effect of carvedilol later a heart
attack come from the CAPRICORN trial, published in 2001. This
study show that when carvedilol be maintain extensive hall in
patients following a heart attack that reduced how well the heart
pumps, the activity of at death`s door was reduced by 23 percent
(95% CI, 2% to 40%, p 0.031). Patients taking carvedilol had a
significantly reduced risk of have another heart attack.
About Neurogen Corporation Neurogen Corporation is a drug
revealing and development firm focus on inconsequential molecule
drugs to amend the in concert of patients scratched from
lawlessness with significant unmet medical stipulation, plus
insomnia, affliction, decline, and chubbiness. Neurogen has
generate a portfolio of compelling alien drug entrant through its
Accelerated Intelligent Drug Discovery (AIDD(TM)) system, its
adroitness in cellular functional assay, and its wisdom in
medicinal chemistry. Neurogen conduct its research and
development in isolation and, when advantageous, collaborate with
world-class pharmaceutical company.
Safe Harbor Statement The statistics here grip release contain
certain forward-looking statement, made pursuant to applicable
securities law, that jumble with risk and uncertainties as
detailed on moment in Neurogen's SEC filings, including its text
recent 10-K. Such forward-looking statements recount to events or
development that we think likely or anticipate will materialize
in the proposed and include, but are not steady to, statements
that are not historical facts relating to the time and event of
anticipated clinical trial, and upcoming mutual aid or new
building of in existence collaborations. Actual results may gala
a inconsistency materially from such forward-looking statements
subsequently of various factor, including, but not limited to,
risks associated with the ingrained faltering of drug research
and development, difficulties or delay in development, testing,
regulatory good wishes, harvest and marketing of any of the
Company's drug candidates, adverse side effects or inadequate
therapeutic efficacy or pharmacokinetic property of the Company's
drug candidates or other properties of drug candidates which
could take home them nasty for commercialization, advancement of
aggressive products, freeze on corporate partner, the Company's
dexterity to retain switch personnel, satisfactoriness of brass
to fund the Company's intended operation and exclusive rights,
product liability and third carnival payback risks associated
with the pharmaceutical industry. For such statements, Neurogen
allege the wadding of applicable laws. Future results may also
differ from previously chitchat results. For prototype, positive
results or safety and tolerability in one clinical study provides
no assurance that this will be true in future studies. Neurogen
disclaim any directed and live out not envision any must to
update these forward-looking statements, stick as may be sought
beneath applicable imperative.
Neurogen Corporation
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