Attached files
| file | filename |
|---|---|
| EX-99.1 - PRESS RELEASE - NeurogesX Inc | d252380dex991.htm |
| 8-K - FORM 8-K - NeurogesX Inc | d252380d8k.htm |
 1
NGX-1998
Phase 2 (C204 Study)
Postherpetic Neuralgia (PHN)
Top-Line Results
November 8, 2011
Exhibit 99.2 |
 2
Study Objectives
1.
Assess preliminary safety and efficacy of 10% and 20%
applied for 5 minutes
2.
Assess preliminary dose response of 20% vs. 10% vs.
Placebo
3.
Determine if topical anesthetic pre-treatment required
4.
Assess if inert placebo is an appropriate control to
maintain the study blinding. |
 3
Phase 2 Study Design
Placebo
NGX-1998 (10%)
NGX-1998 (20%)
30-min pre-treatment
30-min pre-treatment
15-min pre-treatment
15-min pre-treatment
No pre-treatment
No pre-treatment
Placebo
NGX-1998 (10%)
NGX-1998 (20%)
Pre-Rx from
Stage 1
Pre-Rx from
Stage 1
Pre-Rx from
Stage 1
Stage 1
Stage 2
No pre-treatment used in Stage 2 (based on Stage 1 results)
No pre-treatment used in Stage 2 (based on Stage 1 results)
Randomization (2:2:1)
Treatment Application Time: 5 minutes in both Study Stages |
 4
Demographic Characteristics (Baseline)
Placebo
(N=33)
NGX-1998
Total
(N=164)
10%
(N=66)
20%
(N=65)
Average Age
69
70
71
70
Gender (Male)
48%
48%
49%
49%
Average
Duration of PHN
(Year)
3.1
3.3
4.1
3.6
Average NPRS
Score (0-10)
5.9
6.2
6.1
6.1
Concomitant
Neuropathic
Pain
Medications
49%
46%
49%
48% |
 5
Pain Relief Maintained Through 12 Weeks
Following a 5-minute application
-35%
-30%
-25%
-20%
-15%
-10%
-5%
0%
Placebo
NGX-1998 (10%)
NGX-1998 (20%)
LS MEAN % CHANGE FROM BASELINE
OF AVERAGE NPRS SCORES |
 6
Dose Response Data
-30%
-25%
-20%
-15%
-10%
-5%
0%
Placebo
(N=33)
NGX-1998 (10%)
(N=66)
NGX-1998 (20%)
(N=65)
Wks 2-8
Wks 2-12 |
 7
Safety Results
Placebo
(N=33)
NGX-1998
10%
(N=66)
20%
(N=65)
Adverse Events
67%
95%
100%
Local Site Reactions
61%
89%
97%
Serious Adverse
Events
9%
5%
3%
Discontinuation due
to Adverse Events
0%
0%
0% |
 8
C204 Top-Line Study: Our Conclusions
All Study Objectives Were Met
1.
Initial evidence of a dose response:
Treatment Effect: 20% > 10% > Placebo
20% showed similar pain reduction profile to Qutenza
2.
No topical anesthetic pre-treatment required
3.
Excellent safety profile
4.
Suggests true placebo is an appropriate control for future
studies |
 9
Safe Harbor
Forward
looking
statements
may
include,
but
are
not
limited
to,
statements
regarding
the
utility
of
the
data
from
the
completed
clinical
trial
of
NGX-
1998
for
designing
future
clinical
trials,
including
potential
for
non-use
of
anesthetic
pre-treatment
and
use
of
true
placebo.
Such
statements
are
based
on
management's
current
expectations,
but
actual
results
may
differ
materially
due
to
various
risks
and
uncertainties,
including,
but
not
limited
to:
difficulties
or
delays
in
further
clinical
development
of
NGX-1998;
results
from
earlier
clinical
trials
may
not
indicate
similar
results
or
successful
completion
of
future
clinical
trials;
NGX-1998,
or
NeurogesX
approved
product
Qutenza,
may
have
unexpected
adverse
side
effects;
unexpected
or
increased
expenses
in
the
continued
development
of
NGX-1998
or
Qutenza;
market
acceptance
of
NeurogesX’s
existing
product
Qutenza;
and
difficulties
in
maintaining
adequate
funding
or
other
resources
for
NeurogesX
operations
and
development
of
NGX-1998.
For
further
information
regarding
these
and
other
risks
related
to
NeurogesX'
business,
investors
should
consult
NeurogesX'
filings
with
the
Securities
and
Exchange
Commission. |