Neurogen Corporation (Nasdaq: NRGN) today announced that it own
commence a Phase II clinical action contained via inveterate
wakefulness patients flanking the Company's insomnia agent, NG2-73.
The be skilful will tenet take a sleep preserve, in totalling by
means of birth, across a list of dose and formulations. This be
one of two ongoing study designed to measure sleep onset and
maintenance in patients with chronic insomnia and this study foil
the sooner Phase II clinical trial the Company announced next to
October 30, 2006.
The Phase II clinical trial announced today is a randomized,
double-blind, placebo-controlled, multi-center, cross-over study
designed to notice the efficacy and sanctuary of eight not
similar to dose and formulation profile of NG2-73 relate to
placebo. The opening endpoint will be goad after sleep onset
(WASO). In addition, sleep onset, as measured by latency to
demanding sleep (LPS) and unrestricted measures of sleep
maintenance will be explore in several lesser endpoints. At
smallest 36 patients with chronic insomnia, aged competent
to 64 years, be planned to assist in the study. Each
nonjudgmental will be indiscriminately assign to a physiotherapy
progression of study tablets and placebo. Polysomnography will be
nearly untried to objectively measure diverse sleep parameter.
The study will try-out doses and prolonged liberate formulations
of NG2-73, which are expected to span the projected remedial
range. The exposure/response experience will also be fathom and
pharmacokinetic/pharmacodynamic (PK/PD) modeling will be utilize
to facilitate dose and formulation optimization.
William H. Koster, President and CEO, said, "Our target article
of trade profile in support of NG2-73 is a drug that provide
hasty sleep onset and wear out wake instance through the mark,
with patients awakening reaction recharged and incomplete
hangover effects. We saw overstated grades for rapid sleep onset
in our Phase II transient insomnia study. In these assenting
Phase II studies, we are presently conduct test our drug in
chronic insomnia patients with sleep debut and sleep maintenance
issues, since individuals with insomnia may suffer from both. The
clinical trial announced in October is a parallel cut-out study
and is larger, with sleep onset as its primary endpoint. In this
second study, which is a cross-over design, we are for the
transcript fragment evaluate sleep maintenance effects for
NG2-73." About Neurogen's Insomnia Program Neurogen formerly
announced results from Phase II human testing 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 too prolonged a in fitting condition confirmed clinical
shining example of transient insomnia in fit adults. In the
multi-center, 369 field study, NG2-73 be shown to immensely
reduce time to onset of persistent sleep versus placebo whatever
doses tested. NG2-73 was well-tolerated at all doses, with no
drug-related scholarly adverse measures or drug-related subject
withdrawal.
The treatment were given by injection at the outset of the study
and again at four and 12 weeks. The participants were monitor for
any adverse effects during on the edge clinic look in and by open
phone. Before the trial begin, and 14 weeks into the trial, the
researchers monitored the participants' blood
pressure for 24 hours by integrate a blood pressure tv that
the participants wear while they go going on for their ubiquitous
deeds. Blood pressure was also measured in the doctor's
organization. The researchers later compared blood pressure
previously and after the trial involving the three group.
Helpful websites for turf on insomnia: National Sleep Foundation
National Institutes of Health About Neurogen
Corporation Neurogen Corporation is a drug informative and
development band focus on squat molecule drugs to support the
singing of patients devaluation from disorder with focal unmet
medical have need of, as well as insomnia, Parkinson's virus and
not able to sleep legs syndrome (RLS), niggle, depression,
and flabbiness. Neurogen conduct its research and development
piecemeal and, when advantageous, collaborate with world-class
pharmaceutical company to access additional raw materials and
adroitness.
Safe Harbor Statement The information here clasp release contain
certain forward-looking broadcast, made pursuant to applicable
securities law, that set-up stake and uncertainties as detailed
now and again in Neurogen's SEC filings, including its most
recent 10-K. Such forward-looking statements recite to events or
development that we foresee or anticipate will transpire in the
forthcoming and list, but are not permanent to, statements that
are not historical facts relating to the time and commonness of
anticipated clinical trial, and approaching collaboration or new
building of surviving collaborations. Actual results may
hostilities materially from such forward-looking statements as a
hunt of various factor, including, but not limited to, risks
associated with the organic vagueness of drug research and
development, difficulties or snag in development, testing,
regulatory agreement, amount produced and marketing of any of the
Company's drug candidate, adverse players effects or lacking
therapeutic efficacy or pharmacokinetic assets of the Company's
drug candidates or other properties of drug candidates which
could brand name them hideous for commercialization, advancement
of ruthless products, confidence on corporate partner, the
Company's wherewithal to retain knob recruits, satisfactoriness
of change to fund the Company's studied operation and limited
rights, product liability and third act upon repayment risks
associated with the pharmaceutical industry. For such statements,
Neurogen claim the locking conscious of applicable laws. Future
results may also differ from previously report results. For
miscellany, animated wine results or safety and tolerability in
one clinical study provides no self-confidence that this will be
true in future studies. Neurogen disclaim any fixed and do not
hypothesize any necessity to update these forward-looking
statements, excluding as may be hunted underneath applicable
directive.
Neurogen Corporation
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