08/19 08:49 Neurogen Announces that Pfizer Commences Situational Anxiety
Trial of <NRGN.O>
Neurogen Announces that Pfizer Commences Situational Anxiety Trial of Its
Novel Anti-Anxiety Drug
BRANFORD, Conn., Aug. 19 /PRNewswire/ -- Neurogen Corporation
(Nasdaq: NRGN) today announced the commencement of a Phase Ib human
situational anxiety trial of its lead anti-anxiety drug candidate, NGD 91-2.
The situational anxiety trial, which is being conducted by Pfizer Inc,
Neurogen's collaborative partner, is designed both to demonstrate early signs
of clinical efficacy and to provide dosing information for Phase II studies.
The double-blind in-patient study will take approximately five months to
complete, and will involve several groups of normal healthy volunteers,
probably 200 persons in all. Some of the study volunteers will receive one of
several doses of NGD 91-2, some will receive a dose of the commonly prescribed
anxiolytic, Valium(R), and some will receive a placebo. Prior to receiving
drug or placebo, subjects will be placed in a situation known to provoke acute
anxiety. After dosing, each subject will be evaluated to ascertain the
anxiolytic effect of each dose of drug or placebo, the time of onset of
action, and the existence of possible side effects.
"We continue to be very impressed with the extensive investment by Pfizer
in our anxiety program," said Harry H. Penner, Jr., Neurogen's President and
CEO. "While this is an expensive study, the market opportunity for a
fast-acting non-sedating anxiolytic is potentially enormous, and the study
should help to accelerate further clinical development by setting proper
dosages for Phase II."
In a comparable Phase Ib human clinical trial of NGD 91-1, an earlier drug
candidate from this collaboration, Pfizer demonstrated that a single dose of
this small molecule drug candidate acting on specific receptor subtypes of the
GABA neurotransmitter rapidly relieved situational anxiety in humans
comparable to a 10 mg dose of Valium(R), without the sedation associated with
Valium(R). NGD 91-1 did not advance to Phase II because of concerns regarding
its absorption.
Based on the Phase I single and multiple dosing safety studies in normal
human volunteers, NGD 91-2 appears to possess pharmacokinetic characteristics
superior to those of NGD 91-1. Moreover, pre-clinical studies suggest that
NGD 91-2 will perform as well or better than NGD 91-1 in relieving anxiety
without sedation. Concurrent with the situational anxiety trial, Pfizer plans
to perform additional Phase I and Phase II safety studies of NGD 91-2 to
rapidly advance this candidate to pivotal clinical trials.
Neurogen is a leading neuropharmaceutical company whose eleven small
molecule drug programs promise improved treatment for an extensive variety of
neuropsychiatric disorders, including anxiety, obesity, schizophrenia, sleep
disorders, stress-related disorders, dementia, depression, and epilepsy.
Neurogen's growing pipeline of new drug programs, six of which are partnered
with major pharmaceutical companies, derives from its unique integration of
cutting edge neurobiology, medicinal chemistry and molecular biology with its
AIDDsm (Accelerated Intelligent Drug Design) program, a proprietary blend of
combinatorial chemistry with high throughput screening, robotics and
informatics.
The information in this press release contains certain forward-looking
statements that involve risks and uncertainties, particularly those made about
the clinical development of NGD 91-2 and Neurogen's collaboration with Pfizer,
as detailed from time to time in Neurogen's SEC filings, including its most
recent 10-K. Actual results may differ materially from the statements made as
a result of various factors, including, but not limited to, risks associated
with the inherent uncertainty of drug research and development, difficulties
or delays in development, testing, regulatory approval, production and
marketing of NGD 91-2 or any of Neurogen's drug candidates, adverse side
effects or inadequate therapeutic efficacy of NGD 91-2 or any of Neurogen's
drug candidates, advancement of competitive products, dependence Pfizer and
other corporate partners, sufficiency of cash to fund Neurogen's planned
operations and patent, product liability and third party reimbursement risks
associated with the pharmaceutical industry.
SOURCE Neurogen Corporation
-0- 08/19/98
/CONTACT: Stephen R. Davis, or Amy C. Enders, both of Neurogen
Corporation, or 203-488-8201; or media, Lori Gosset of Robert Marston &
Assoc., 212-371-2200, for Neurogen Corporation/
/Web site: neurogen.com
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