Societal CDMO (SCTL) 8-K Recro Pharma Reports Positive Top-Line Results from Pivotal Phase III Clinical Trial of IV Meloxicam

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.