answer study h… · the psychosocial impact of rosacea can be severe and debilitating, but clear...

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ANSWER StudyImproving Papular-Pustular

Rosacea Together

The Impacts of Rosacea Go More than Skin Deep Patients with rosacea suffer from psychological symptoms that impact their everyday life. According to a literature review of over 17 studies, the disease can lead to issues beyond the surface to cause social anxiety, depression and a lower Quality of Life (QOL).1

The psychosocial impact of rosacea can be severe and debilitating, but clear skin can reduce the impact rosacea has on every patient.

spent on skin care for patients with high burden

49% of “clear” patients reported rosacea had no impact on their QOL vs 30% for the “almost clear” patients (P ≤0.05)

Data from an online survey of 710 rosacea patients. Data is from the global survey of total patient population.

DLQI = Dermatology Life Quality Index; QOL = quality of life.

3.5 hours more per week

of high burden patients (DLQI >10) are willing to trade a year or more of their life for a rosacea cure

55%rosacea has at least a moderate impact on their life

For

5 0%of patients

Perc

enta

ge o

f Pat

ient

s

With

DLQ

I≤1

“CLEAR”

n = 98

60

50

40

30

20

10

0n = 116

“ALMOST CLEAR”

1

SOOLANTRA® Cream: Pivotal Study Information Rapid relief. Continuous improvement over time.

Study Design

The efficacy and safety of SOOLANTRA® (ivermectin) Cream, 1% QD* was evaluated in 1,371 subjects aged ≥18 years in 2 identically designed, phase 3 trials. Final results were comparable between the 2 studies, with the least-favorable results presented here.2,3

Indication

SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea.

Study 1

SOOLANTRA Cream

(n = 451)

SOOLANTRACream

(n = 459)

Vehicle Cream(n = 232)


Total(n = 683)

Total(n = 688)

Gender, n (%) Male Female

IGA, n (%) 3 (moderate) 4 (severe)

Inflammatory lesions, n Mean (SD) Median

Race, n (%) White Black or African American Asian Other

Mean age, y (SD)

Study 2

137 (30.4)314 (69.6)

49.9 (912.15)

437 (96.9)6 (1.3)3 (0.7)5 (1.1)

369 (81.8)82 (18.2)

31.0 (14.28)27.0

80 (34.5)152 (65.5)

51.6 (11.92)

220 (94.8)3 (1.3)3 (1.3)6 (2.6)

191 (82.3)41 (17.7)

30.5 (14.44)26.5

217 (31.8)466 (68.2)

50.4 (12.09)

657 (96.2)9 (1.3)6 (0.9)11 (1.6)

560 (82.0)123 (18.0)

30.9 (14.33)27.0

145 (31.6)314 (68.4)

50.5 (12.35)

438 (95.4)6 (1.3)10 (2.2)5 (1.1)

346 (75.4)113 (24.6)

33.3 (13.62)30.0

84 (36.7)145 (63.3)

49.5 (12.16)

218 (95.2)4 (1.7)5 (2.2)2 (0.9)

176 (76.9)53 (23.1)

32.2 (13.86)29.0

229 (33.3)459 (66.7)

50.2 (12.29)

656 (95.3)10 (91.5)15 (2.2)7 (1.0)

522 (75.9)166 (24.1)

32.9 (13.70)29.0

SD=standard deviation. QD=once daily.*Subjects were instructed to apply once daily every day at bedtime.**Data shown are from one of two pivotal trials.

SOOLANTRA Cream Pivotal Studies: Subject Demographics**

2

Higher IGA Success Rate with SOOLANTRA Cream vs Vehicle Cream at Weeks 4, 8 and 12 in Two Pivotal Studies2,3

Greater Inflammatory Lesion (IL) Reduction with SOOLANTRA Cream vs Vehicle Cream at Weeks 2, 4, 8 and 12 in Pivotal Studies2,3

Week 2

Per

cen

tag

e o

f S

ub

ject

s

Per

cen

tag

e o

f S

ub

ject

s

45

35

15

5

0

25

40

30

20

10

Week 4 Week 8 Week 12

SOOLANTRA Cream(n = 451)

Intent-to-treat population,last observation carried forward

‡P< 0.05†P< 0.001


38.4†

23.1†

11.69.95.63.8

10.9‡

2.2

Week 2

45

35

15

5

0

25

40

30

20

10

Week 4 Week 8 Week 12

40.1†

27.5†

18.8

12.25.7

3.5

11.8‡

2.6

Study 1 Study 2

Week 2

Mea

n C

han

ge

inIn

flam

mat

ory

Les

ion

Co

un

t

Mea

n C

han

ge

inIn

flam

mat

ory

Les

ion

Co

un

t

–5

–10

–15

–20

–25

0

–5

–10

–15

–20

–25

0Week 4 Week 8 Week 12 Week 2 Week 4 Week 8 Week 12

SOOLANTRA CreamSOOLANTRA CreamSOOLANTRA(n = 451)

Intent-to-treat population, last observation carried forward

*P< 0.001P< 0.001PVehicle Cream(n = 232)

Study 1

-7.8-9.1

-14.3*

-19.8*

-20.5*

-8.8

-13.6*

-17.9*

-20.5*

-6.3

-11.2-13.4

-7.7-5.1

-10.1-12.0

Statistically significant mean change in IL count as early as week 2

Study 2

Statistically significant mean change in IL count as early as week 2


Intent-to-treat population, last observation carried forward

*P< 0.001P< 0.001PVehicle Cream(n = 229)

IGA success was defined as achieving clear or almost clear.

Inflammatory lesion count continued to improve throughout the study

The most common adverse reactions (incidence ≤ 1%) included skin burning sensation and skin irritation

3

SOOLANTRA Cream Long-Term Safety Study: Treatment-Related AEs4**

With SOOLANTRA Cream, Clearer Is Possible!• Proposed Dual MOA of Ivermectin* – Anti-inflammatory and anti-parasitic activity of ivermectin has been shown5,6

• Superior Efficacy to METROCREAM Topical Cream, 0.75%

– A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of SOOLANTRA Cream once daily with METROCREAM Topical Cream, 0.75% twice daily in 962 subjects 18 years or older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period – SOOLANTRA Cream has a higher IGA success rate** in clinical trials3,7

– 84.9% of SOOLANTRA Cream-treated subjects achieved IGA success vs 75.4% of METROCREAM Topical Cream, 0.75%-treated subjects at week 16 (P < 0.001)7

– 60% more subjects became clear (IGA = 0) with SOOLANTRA Cream vs METROCREAM Topical Cream, 0.75% – 33% more subjects treated with SOOLANTRA Cream did not need retreatment (subjects were observed every 4 weeks from week 16 to week 52)8

• Highly Tolerable – SOOLANTRA Cream was safe and well tolerated – SOOLANTRA Cream was better tolerated than azelaic acid 15% gel and METROCREAM Topical Cream, 0.75%8

– SOOLANTRA Cream is safe for up to 52 weeks of treatment – In clinical trials, the most common related adverse reactions with SOOLANTRA Cream (incidence ≤1%) included skin-burning sensation and skin irritation4,7

– SOOLANTRA Cream utilizes CETAPHIL® Moisturizing Cream as the basis for the vehicle2

– No severe or serious AEs were considered related to SOOLANTRA Cream or AzA

Study 1

SOOLANTRA Cream(n = 412)n (%)

Vehicle/Azelaic Acid(n = 210)


Number of subjects that experienced Treatment EmergentAdverse Events (TEAEs)

Skin irritation Dry skin Pain of skin

Number of subjects that had TEAEs related to study drug*


Study 2

249 (60.4)

8 (1.9)

2 (0.5)2 (0.5)0 (0)

127 (60.5)

14 (6.7)

3 (1.4)4 (1.9)5 (2.4)

254 (59.3)

9 (2.1)

1 (0.2)0 (0)

1 (0.2)

122 (58.7)

12 (5.8)

4 (1.9)2 (1.0)0 (0)

A greater percentage of subjects on vehicle/azelaic acid had treatment related AEs vs subjects using SOOLANTRA Cream

No severe or serious AEs were considered related to SOOLANTRA Cream or AzA. Five subjects in SOOLANTRA Cream group and 4 subjects in the AzA group discontinued from the study due to an AE during Part B. None of the AEs that led to discontinuation in the SOOLANTRA Cream group were considered related to SOOLANTRA Cream.

**A subject was counted once even if the subject experienced more than 1 AE during the study.

*The mechanism of action of SOOLANTRA Cream in treating rosacea lesions is unknown.**IGA success was defined as IGA score of 0 (clear) or 1 (almost clear).

4

ORACEA® Capsules: Pivotal Study Information The only FDA-approved oral therapy proven to be e�ective for the inflammatory lesions of rosacea.

Study Design

The efficacy and safety of once-daily non-antibiotic dose doxycycline (40-mg doxycycline monohydrate 30-mg immediate-release and 10-mg delayed release beads) for the treatment of rosacea was evaluated for 537 subjects aged > 18 years in 2 identically designed, phase 3 trials.

Indication

ORACEA Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

Gender, n (%) Male Female

IGA, n (%) 2 (mild) 4 (moderate) 4 (severe)

Inflammatory lesions, n Mean (SD)

ORACEA Capsules(n = 127)

Mean age, y (SD)

36 (28.3)91 (71.7)

46.8 (13.2)

8 (6.3)67 (52.8)52 (40.9)

19.5 (8.8)

Placebo(n = 124)

29 (23.4)95 (76.6)

47.6 (11.5)

10 (8.1)65 (52.4)49 (39.5)

20.3 (10.4)


78 (33.8)94 (66.2)

46.3 (12.7)

17 (12.0)77 (54.2)48 (33.8)

20.5 (11.7)

Placebo(n = 144)

49 (34.0)95 (66.0)

47.6 (NR)

7 (4.9)80 (55.6)57 (39.6)

21.2 (12.5)

Study 1 Study 2

proven to be e�ective for the inflammatory

IGA = Investigator’s Global Assessment.

Study Demographics9

5

ORACEA Capsules Significantly Reduced Inflammatory Lesions vs Placebo2,9

*Total inflammatory lesion count = papules + pustules.

†P=0.005; P<0.001

ORACEA Capsules Pivotal Studies: Safety10Study 1


Placebo(n = 268)

Adverse Events,n (%)

Adverse Events,n (%)

Placebo

Nasopharyngitis

Pharyngolaryngeal pain

Sinusitis

Nasal congestion

Fungal infection

Influenza

Diarrhea

Abdominal pain upper

Abdominal distention

Stomach discomfort

Dry mouth

Hypertension

Blood pressureincrease

Asparateaminotransferaseincrease

Blood lactatedehydrogenaseincrease

Blood glucoseincrease

Anxiety

Pain

Back pain

Sinus headache

13 (5%)

3 (1%)

7 (3%)

4 (2%)

5 (2%)

5 (2%)

12 (5%)

5 (2%)

3 (1%)

3 (1%)

3 (1%)

8 (3%)

9 (3%)

2 (1%)

2 (1%)

2 (1%)

1 (0%)

3 (1%)

7 (3%)

1 (0%)

1 (0%)

2 (1%)

0 (0%)

2 (1%)

4 (2%)

6 (2%)

4 (2%)

3 (1%)

4 (2%)

4 (2%)

3 (1%)

3 (1%)

1 (0%)

2 (1%)

1 (0%)

0 (0%)

0 (0%)

1 (0%)

0 (0%)

0 (0%)

(n = 268)ORACEA Capsules

(n = 269)

Study 2

0

–10

–20

–30

–40

–50

–60

–70

Baseline

Study 1 Study 2

Week 3 Week 6 Week 12 Week 16

0

–10

–20

–30

–40

–50

–60

–70

Baseline Week 3 Week 6 Week 12 Week 16

ORACEA Capsulesn = 127

Placebon = 124

Mea

n C

han

ge

in T

ota

lIn

flam

mat

ory

Les

ion

Co

un

t (%

)*

Mea

n C

han

ge

in T

ota

lIn

flam

mat

ory

Les

ion

Co

un

t (%

)*

ORACEA Capsulesn = 142

Placebon = 144

6

ANSWER Study

Let’s Clear up the Facts Combination treatment has the potential to improve outcomes. For this study, we added ORACEA® (doxycycline, USP) 40 mg Capsules to SOOLANTRA® (ivermectin) Cream, 1% to measure efficacy and ensure the treatment approach aims for “clear”. Clear is defined as IGA score of 0 according to the IGA (Investigator Global Assessment) scale, which is commonly used by dermatologists. Both molecules have independent cooperative effects on the inflammatory pathway of rosacea.11

ANSWER Study Overview11

Study objective: Evaluate efficacy of ORACEA Capsules plus SOOLANTRA Cream vs SOOLANTRA Cream alone in severe rosacea with papulopustular lesions

Design: Multicenter, randomized, investigator-blinded, parallel-group comparison, 12-week study

†Subjects were provided with non-investigational products that they were required to use alongside their treatments for the duration of the study. These products were Cetaphil Redness Relieving Foaming Face Wash and Cetaphil Redness Relieving Facial Moisturizer SPF 30.

IGA = Investigator’s Global Assessment.

The mechanism of action of SOOLANTRA Cream in treating rosacea lesions is unknown. The mechanism of action of ORACEA Capsules in the treatment of inflammatory lesions of rosacea is unknown.

Patient assessments atweeks 4, 8 and 12

Investigator-blinded

Baseline 12 weeks

SOOLANTRA Cream (QD)+ Placebo

SOOLANTRA Cream (QD)+ ORACEA Capsules

1:1 Randomization

Adults aged > 18 years withsevere rosacea (IGA 4),

with 20 to 70 inflammatory lesions(papules and pustules) and

<2 nodules on the face†

11

7

ANSWER Study Design

Baseline Characteristics

Patients in two groups were well-balanced in terms of demographics, skin phototype and severity and duration of disease.

Baseline demographic data11

Baseline disease characteristics11

Safety Data

The combination of SOOLANTRA

Cream + ORACEA Capsules

treatment resulted in no

discontinuations of treatment due to

related AEs.

Primary Endpoint

Percentage change from baseline in

inflammatory lesion counts at Week 12.

SOOLANTRA Cream +Placebo

SOOLANTRA Cream +ORACEA Capsules

Total

Patient population

Gender

Age

Race

N

Male

Female

Mean

SD

White

Black or African American

Asian

Other

138

58 (42.0%)

80 (58.0%)

51.6

13.3

136 (98.6%)

0 (0.0%)

2 (1.4%)

0 (0.0%)

135

60 (44.4%)

75 (55.6%)

52.4

13.5

133 (98.5%)

1 (0.7%)

0 (0.0%)

1 (0.7%)

273

118 (43.2%)

155 (56.8%)

52.0

13.4

269 (98.5%)

1 (0.4%)

2 (0.7%)

1 (0.4%)

SOOLANTRA Cream +Placebo(n=138)

SOOLANTRA Cream +ORACEA Capsules

(n=135)

Total(n=273)

Facial Inflammatorylesion counts

IGA

CEA

Mean

SD

4 = Severe

1 = Almost clear

4 = Mild erythema

4 = Moderate erythema

4 = Severe erythema

Mean

SD

39.5

12.9

138 (100.0%)

3 (2.2%)

9 (6.5%)

42 (30.4%)

84 (60.9%)

3.5

0.72

38.5

11.8

135 (100.0%)

1 (0.7%)

13 (9.6%)

40 (29.6%)

81 (60.0%)

3.49

0.70

39.0

12.3

273 (100.0%)

4 (1.5%)

22 (6.5%)

82 (30.0%)

165 (60.4%)

3.49

0.71

SD = standard deviation.

8

Dual Therapy Demonstrated a Significant Reduction in Inflammatory Lesions from Baseline vs Monotherapy at Week 1211

Dual Therapy Significantly Increased the Percentage of Subjects Achieving 100% Reduction of Inflammatory Lesions by Week 1211

0

10

20

30

40

50

60

70

80

90

100

Baseline Week 4 Week 8 Week 12

SOOLANTRA Cream + ORACEACapsulesSOOLANTRA Cream + Placebo

Mea

n P

erce

nta

ge

Red

uct

ion

inIn

flam

mat

ory

Les

ion

s fr

om

Bas

elin

e (%

)*

Dual therapy worked significantly faster than monotherapy with differences seen as early as Week 4 Mean reduction in % of inflammatory lesions from baseline to Week 12 (ITT/LOCF)

P=0.007

P=0.012

39.27

61.44

73.56

48.15

69.14

P=0.032

80.29

P=0.006

7.2

17.8

20

18

16

14

12

10

8

6

4

2

0

% Subjects Achieving 100% Reduction of Inflammatory Lesions at 12 weeks

2x as manysubjects on combination therapy achieved 100% lesion reduction vs monotherapy

SOOLANTRA Cream + Placebo SOOLANTRA Cream + ORACEA Capsules

Per

cen

tag

e o

f S

ub

ject

s (%

)

Baseline: SOOLANTRA Cream + ORACEA Capsules (n=135), SOOLANTRA Cream + Placebo (n=138); Week 12: SOOLANTRA Cream + ORACEA Capsules (n=135), SOOLANTRA Cream + Placebo (n=138)

ITT/LOCF = intention to treat/last observation carried forward.


11

9


66.7% of Subjects (All IGA 4) Achieved Clear/Almost Clear (IGA 0 or 1) with Dual Therapy at Week 1211

54.3 54.8

59.4%66.7%

5.111.9

80

70

60

50

40

30

20

10

0

Significantly more patients using combination treatment achieved clear ( IGA 0)by week 12 (11.9%) vs monotherapy (5.1%; P=0.043)

Clear = No inflammatorylesions present, no erythema

Almost Clear = Very fewsmall papules/pustules, verymild erythema present

SOOLANTRA Cream + Placebo SOOLANTRA Cream + ORACEACapsules

Per

cen

tag

e o

f P

atie

nts

(%

)

P=0.043

Treatment-Related Adverse Events Were Similar in the Two Treatment Arms11

In clinical trials with SOOLANTRA Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation

In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase

*Subjects with at least one event from baseline to end of study. Numbers in columns cannot be added because a given subject may have reported more than one AE.

SOOLANTRA Cream + Placebo(n=138)

N subjects*n events % N subjects*n events %

SOOLANTRA Cream +ORACEA Capsules (n=135)

Related AEs

Related dermatological AEs

Related worsening of rosacea AEs

Related severe AEs

Related serious AEs

Related AEs leading to discontinuation

14

4

0

2

0

6

10

4

0

2

0

3

7.2

2.8

0.0

1.4

0.0

2.2

6

3

1

0

0

0

6

3

1

0

0

0

4.4

2.2

0.8

0.0

0.0

0.0

The combination of SOOLANTRA Cream + ORACEA Capsules treatment resulted in no discontinuations of treatment due to related AEs11

10

Both Treatment Regimens Resulted in High Patient Satisfaction11

Week 12: SOOLANTRA Cream + ORACEA Capsules (n=125), SOOLANTRA Cream + Placebo (n=129)

SOOLANTRA Cream + Placebo:% of patients (n) Satisfaction domain

SOOLANTRA Cream +ORACEA Capsules:

% of patients (n)Overall satisfaction(response: satisfied or very satisfied)

Time the study regimen took to work(response: satisfied or very satisfied)

Easy to incorporate into daily routine(response: satisfied or very satisfied)

How bothered by side effects (response: satisfied or very satisfied)

Compared to last treatment (response: better or a lot better)

79.8% (103)

83.8% (108)

98.4% (127)

76.7% (99)

69% (89)

93.6% (117)

88.0% (110)

98.4% (123)

84.0% (105)

72.0% (90)

DLQI Scores Improved for Both Physiological and Psychological Symptoms at Week 12 for Both Treatment Arms2

Baseline: IVM + DMR n=135 IVM + PBO n=138; Week 12 IVM + DMR n=125 IVM + PBO n=129 DLQI, dermatology life quality index; DMR, doxycycline modified release; IVM, ivermectin; PBO, placebo

80

90

100

70

60

50

40

30

20

10

0

80

90

100

70

60

50

40

30

20

10

0

Patient-reported outcomes for embarrassment and self-consciousness at baseline and Week 12

Patient-reported outcomes for itchiness, soreness,painfulness and stinging at baseline and Week 12

Baseline Week 12 Baseline Week 12

0: Not at all

1: A little

2: A lot

3: Very much

Pat

ien

t P

op

ula

tio

n (

%)

Pat

ien

t P

op

ula

tio

n (

%)21.7.7. 23.7.7.

63.672.8

15.9 20.0

66.772.0

SOOLANTRACream + Placebo

(n=138)

SOOLANTRA Cream + ORACEA Capsules (n=135)

SOOLANTRACream+ORACEACapsules (n=125)


(n=129)


(n=138)

SOOLANTRA Cream + ORACEACapsules (n=135)

SOOLANTRACream+ORACEACapsules (n=125)


(n=129)

11

Before/After

Subject 5433_209-IVM + DMR

98% Lesion Reduction11

IGA = 4 IL = 55

Baseline

IGA = 1 IL = 1

Week 12

80% Lesion Reduction11

Subject 5433_274 – IVM + DMR

IGA = 4 IL = 66 IGA = 3 IL = 13

Baseline Week 12

12

CLEAR* Analysis: Overview2

Understanding the Importance of Clear Skin

Post-hoc analysis of phase 2 and phase 3 studies of SOOLANTRA Cream

OBJECTIVE: Define the benefit of being “clear” versus “almost clear” in subjects considered a “success” with treatment

All subjects who achieved clear (IGA=0) or almost clear (IGA=1) were combined regardless of treatment (SOOLANTRA Cream and METROCREAM Topical Cream, 0.75%) and vehicle2

Subjects Who Achieve Clear Remain Treatment- Free for 5 Months Longer Than Subjects Who Achieve Almost Clear12

100

90

80

70

60

50%

40

30

20

10

00 14 28 42 46 70 84 98 112 126 140 154 168 182 196 210 224 238 252 1 2 3 4 5 6 7 8

Pooled Analysis of Treatment-Free Time After Treatment for Rosacea*

Time in DaysEnd of

Treatment Median Time to Relapse (months)

IGA at the end of the treatment period Clear Almost clear

% o

f Su

bje

ct R

emai

nin

g W

ith

ou

t R

elap

se

P < 0.0001

P < 0.0001

“Clear” (IGA 0)Median time to treatment (relapse): >8 months

“Almost clear” (IGA 1)Median time to treatment (relapse): 3 monthsn

= 48

7 n

= 2

70

*Pooled post-hoc analysis of 4 studies evaluating SOOLANTRA Cream, 1%, METROCREAM Topical Cream, 0.75%, or vehicle in subjects with inflammatory papules and pustules of rosacea.

*CLEAR = Change the Level of Expectation of Achievement for Rosacea

13

1. Rosacea: Beyond the visible online report, BMJ Hosted Website (http://hosted.bmj.com/ rosaceabeyondthevisible). Last accessed: June 2018.

2. Data on file. Galderma Laboratories, L.P.

3. Stein Gold L, et al. J Drugs Dermatol. 2014;13(3):316–323.

4. Stein Gold L, et al. J Drugs Dermatol. 2014;13(11):1380–1386.

5. Ci X, et al. Fundam Clin Pharmacol. 2009;23:449–455.

6. SchallerM, et al. J EurAcadDermatolVenereol. 2017;31(11):1907–1911.

7. TaiebA, et al. BrJ Dermatol. 2015;172(4):1103–1110.

8. TaiebA, et al. J Eur Acad Dermatol Venereol. 2016;30(5):829–836.

9. Del Rosso JQ, et al. J Am Acad Dermatol. 2007;56:791–802.

10. Oracea [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P., 2014.

11. Data on file. Study #113322. Fort Worth, TX; Galderma Laboratories, L.P.

12. Webster G, et al. J Dermatol Treat. 2017;28(5):469–474.

References

Important Safety Information

SOOLANTRA

Indication: SOOLANTRA® (ivermectin) Cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Not for oral, ophthalmic or intravaginal use. Adverse Events: In clinical trials with SOOLANTRA Cream, the most common adverse reactions (incidence ≤1%) included skin burning sensation and skin irritation.

ORACEA

Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years). Although photosensitivity was not observed in clinical trials, ORACEA Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established.

*30 mg immediate release & 10 mg delayed release beads

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying Prescribing Information for SOOLANTRA Cream and ORACEA Capsules.

14

ANSWER Study Summary

Dual therapy worked significantly faster than monotherapy with differences seen as early as Week 4

Combination treatment significantly increased the number of patients reaching “clear” (IGA 0) and those achieving 100% reduction in inflammatory lesions by Week 12

Patients who used dual therapy had higher overall treatment satisfaction

The safety profile of ORACEA Capsules and SOOLANTRA Cream in combination was generally well tolerated and led to no discontinuations of treatment due to related side effects

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answer study h… · the psychosocial impact of rosacea can be severe and debilitating, but clear...

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