Attached files
| file | filename |
|---|---|
| EX-99.1 - EX-99.1 - Recro Pharma, Inc. | d288858dex991.htm |
| 8-K - 8-K - Recro Pharma, Inc. | d288858d8k.htm |
 Study REC-15-015
A Phase 3, Multicenter, Randomized,
Double-Blind, Placebo-Controlled,
Evaluation of the Efficacy and Safety of
N1539 Following Abdominoplasty
1 Exhibit 99.2 |
 Study REC-15-015
Study Design • Multicenter, Multi-dose, Randomized, Double-blind, Placebo- controlled • 219 subjects randomized to IV Meloxicam (N1539) 30 mg or Placebo – Study medication administered q24 hours up to 3 doses – 98% of subjects completed the 48 hour assessments • Standard analgesia design – Pain Intensity assessments (SPID24 = Primary Endpoint) – Use of rescue medication – Time to onset – Patient Global Assessment of Pain Control 2 |
 Study REC-15-015
Primary Endpoint –
SPID24 3 p = 0.0145 0 1,000 2,000 3,000 4,000 5,000 N1539 30 mg (N = 110) Placebo (N = 109) |
 Study REC-15-015
Summary of Secondary Endpoints
4 SPID6, Time to Meaningful Pain Relief and First Rescue, Number of Subjects rescued 0-24 and 0-48
hours, %
Subjects
with
30
and
50%
Improvement
within
6
Hours
and
50%
within
24
hours,
PGA
of
Pain
Control at 24 hours were not significantly different
between treatment groups.
Parameter
p-value
SPID12
0.0434
SPID48
0.0040
SPID24-48
0.0028
Number of Subjects Rescued 24-48 Hours
0.0014
Number of Times Rescued 0-24 Hours
0.0275
Number of Times Rescued 24-48 Hours
0.0009
Number of Times Rescued 0-48 Hours
0.0027
Time to Perceptible Pain Relief
0.0050
%
Subjects
with
30%
Improvement
-
24
Hours
0.0178
PGA of Pain Control at 48 hours
0.0027 |
 Study REC-15-015
Adverse Events –
2% in the N1539 group
5 n (%) of Subjects N1539 30 mg Placebo Preferred Term (N=110) (N=109) Subjects with 1 TEAE 58 (52.7) 80 (73.4) Nausea 30 (27.3) 41 (37.6) Headache 13 (11.8) 18 (16.5) Vomiting 5 ( 4.5) 10 ( 9.2) Dizziness 4 ( 3.6) 10 ( 9.2) **Four (4) subjects experienced Serious Adverse Events during this study. Three
subjects were randomized to placebo and one to
N1539. |