IMPORTANT SAFETY INFORMATION PRESCRIBING INFORMATION PATIENT SITE

INTRODUCING SEYSARA

Seysara (sarecycline) is active in vitro against most isolates of P. acnes; however, the
clinical significance is unknown.
Bacteria icon

P. acnes strains displayed a low propensity for the development of resistance to sarecycline.1

  • At 4 to 8 times the minimum inhibitory concentration (MIC), the spontaneous mutation frequency of P. acnes in the presence of sarecycline is 10-10 (one in ten billion)1

In accordance with current guidelines for antibiotic stewardship, SEYSARA provides a valid option to treat moderate to severe acne.

AAD GUIDELINES FOR ANTIBIOTIC USE

When prescribing systemic antibiotics, the issue of bacterial resistance remains a major concern4

Limited systemic antibiotic use is urged due to the incidence of IBD, pharyngitis, Clostridium difficile infection, and induction of Candida vulvovaginitis 4

SEYSARA

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P. acnes strains displayed a low propensity for the development of resistance to sarecycline1*

See Limitations of Use and Warnings and Precautions regarding bacterial resistance in the accompanying Important Safety Information

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Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established

An established safety profile with low rates of GI side effects1-3

The most common adverse reaction in pivotal trials (incidence ≥ 1%) was nausea: SEYSARA (3.1%) versus placebo (2.0%).1

See Warnings and Precautions regarding C. difficile associated diarrhea (CDAD) in the accompanying Important Safety Information

Vulvovaginal mycotic infection (0.8%) and vulvovaginal candidiasis (0.6%) occurred in <1% of female SEYSARA patients1,2

 

See detailed safety and tolerability profile here.

AAD, American Academy of Dermatology; GI, gastrointestinal; IBD, inflammatory bowel disease.
* With spontaneous mutation frequencies being 10−10 at 4–8 × MIC.1

The sarecycline molecule
CDC GUIDELINES FOR ANTIBIOTIC STEWARDSHIP

Overuse of broad-spectrum antibiotics is problematic because of their potential to induce bacterial resistance; clinical practice guidelines recommend the use of more targeted agents5

Select the correct medication, dose, and duration of treatment for your patient6

SEYSARA

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Developed specifically for the treatment of moderate to severe acne vulgaris1

P. acnes strains displayed a low propensity for the development of resistance to sarecycline1*

Sarecycline is active in vitro against most isolates of P. acnes; however, the clinical significance is unknown1

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Tailored, weight-based, once-daily dosing, with or without food1

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With efficacy data up to Week 12 and safety data up to 12 months1-3

CDC, Centers for Disease Control and Prevention.
* With spontaneous mutation frequencies being 10−10 at 4–8 × MIC.1

The sarecycline molecule
CHOOSE SEYSARA: THE ONLY ORAL ANTIBIOTIC FOR ACNE WITH
AN FDA-APPROVED LABEL DESCRIBING A LOW PROPENSITY
FOR ANTIBIOTIC RESISTANCE IN ACNE1

AAD, American Academy of Dermatology; CDC, Centers for Disease Control and Prevention; FDA, Food and Drug Administration.

CLINICAL STUDIES

PATIENT POPULATION1-3

2,002 subjects (ITT)
49% 9-17 years of age
51% 18-45 years of age
57% women
78% white
15% Black/African American
7% other
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KEY INCLUSION CRITERIA2

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Weight:
33-136 kg (73-300 lbs)
Icon of a face with acne
Facial acne vulgaris with:
  • Lesions: 20 to 50 inflammatory; ≤100 non-inflammatory
  • Nodules: ≤2
  • IGA score: 3 (moderate) or 4 (severe)

  • KEY EXCLUSION CRITERIA2

    Subjects were excluded from the study if they had received any of the following treatments within 12 weeks prior to randomization:

    • Hormonal contraception
    • Systemic retinoids
    • Systemic corticosteroids
    • Androgens
    • Anti-androgens

IGA, investigator’s global assessment; ITT, intent-to-treat.

SEYSARA: EXTENSIVELY STUDIED IN TWO PHASE 3 CLINICAL TRIALS

STUDY 1* and STUDY 2�  were two identically designed, 12-week, multicenter, randomized, double-blind, placebo-controlled trials.1,2‡

Clinical efficacy of SEYSARA at Week 121

STUDY 1a
STUDY 2b
SEYSARA (n = 483) Placebo (n = 485)
SEYSARA (n = 519) Placebo (n = 515)
Investigator’s Global Assessment
IGA Success
21.9% 10.5%
22.6% 15.3%
Inflammatory Lesions
Mean absolute reduction
Mean percent reduction
15.3 10.2

52.2% 35.2%
15.5 11.1

50.8% 36.4%

a Study 1 = SC1401.
b Study 2 = SC1402.

CO-PRIMARY ENDPOINTS

Compared with placebo, SEYSARA demonstrated:

Downward arrow icon
Greater mean absolute reduction from baseline
in inflammatory lesion counts at Week 121,2
IGA success icon
An increased rate of IGA success§ at Week 121,2

SECONDARY ENDPOINTS

Line chart showing Mean reduction from baseline in inflammatory lesion counts across 12 weeks

Compared with placebo, SEYSARA demonstrated:

3 week reduction icon
Significant inflammatory lesion count reduction in as little as 3 weeks1
50% icon
~50% mean reduction of inflammatory lesions at Week 121

IGA, investigator’s global assessment.
* Study 1 = SC1401.
�  Study 2 = SC1402.
‡ In both studies, SEYSARA was administered orally once daily for 12 weeks as 60-mg, 100-mg, or 150-mg tablets, based on patient weight.2
§ IGA success was defined as ≥2-point improvement from baseline in IGA scale for inflammatory lesions of acne, and a score of 0 (clear) or 1 (almost clear).2

FACIAL AND TRUNCAL DATA

EARLY ONSET FOR VISIBLE RESULTS1

Significant decrease in facial acne in as little as 3 weeks, with consistent results at Week 12 across gender and ethnicity subgroups.1,2

Series showing progressive reduction in lesions on a subject's face at baseline, week 3 and week 12 in study 1
Series of progressive reduction in lesions on a subject's face at baseline, week 3 and week 12 in study 2

Actual clinical trial subjects. Results may vary.

a Study 1 = SC1401.
b Study 2 = SC1402.
c Week 3 results were secondary outcome measures.

In addition to facial results, SEYSARA showed statistically significant improvement in
IGA scores in both chest and back acne at Week 12.2*,� 
Chest icon
CHEST: IGA SUCCESSa
Bar chart showing IGA success of Study 1 for chest. 19.6% success with placebo, 29.6% success with once-daily Seysara.
Bar chart showing IGA success of Study 2 for chest. 21.6% success with placebo, 36.6% success with once-daily Seysara.
Back icon
BACK: IGA SUCCESSa
Bar chart showing IGA success of Study 1 for back. 17.1% success with placebo, 32.9% success with once-daily Seysara.
Bar chart showing IGA success of Study 2 for back. 25.7% success with placebo, 33.2% success with once-daily Seysara.

a Post-hoc analysis.
b Study 1 = SC1401.
c Study 2 = SC1402.

IGA, investigator’s global assessment.
* Severity of non-facial IGA success was defined as ≥2-point improvement from baseline in non-facial IGA score, and a score of 0 (clear) or 1 (almost clear).
�  IGA success data for chest and back were analyzed post-hoc.

TOLERABILITY

DEMONSTRATED SAFETY PROFILE

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Who participated in the study?

Studied in over 2000 patients with moderate to severe acne across three controlled clinical trials.2,3

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What is SEYSARA’s safety profile?

SEYSARA has a proven safety profile with low rates of GI, vestibular, and phototoxic side effects.1-3
  • The most common adverse reaction (incidence ≥1%) was nausea: SEYSARA 3.1% vs placebo 2.0%.1
9 year old child icon

Can SEYSARA be taken by preteens?

Approved for use in children as young as 9 years of age.1

PHASE 3 CLINICAL STUDIES2,3

STUDY 1a
Event, n (%)
SEYSARA
(n = 481)
Placebo (n = 483)
GI effects
Nausea
22 (4.6)
12 (2.5)
Vomiting
10 (2.1)
7 (1.4)
Abdominal pain
6 (1.2)
6 (1.2)
Abdominal discomfort
5 (1.0)
1 (0.2)
Diarrhea
5 (1.0)
8 (1.7)
Vestibular effects
Dizziness
3 (0.6)
7 (1.4)
Motion sickness
0
0
Tinnitus
0
0
Vertigo
0
0
Phototoxic effects
Photosensitivity
0
0
Sunburn
3 (0.6)
2 (0.4)
STUDY 2b
Event, n (%)
SEYSARA
(n = 513)
Placebo
(n = 513)
GI effects
Nausea
10 (1.9)
5 (1.0)
Vomiting
3 (0.6)
2 (0.4)
Abdominal pain
3 (0.6)
1 (0.2)
Abdominal discomfort
2 (0.4)
2 (0.4)
Diarrhea
6 (1.2)
6 (1.2)
Vestibular effects
Dizziness
2 (0.4)
4 (0.8)
Motion sickness
1 (0.2)
1 (0.2)
Tinnitus
0
0
Vertigo
0
0
Phototoxic effects
Photosensitivity
1 (0.2)
0
Sunburn
4 (0.8)
1 (0.2)

a Study 1 = SC1401.
b Study 2 = SC1402.

  • The following additional adverse drug reactions occurred in <1% of female SEYSARA subjects1-3:

    • Vulvovaginal mycotic infection (0.8%)
    • Vulvovaginal candidiasis (0.6%)

SAFETY AND TOLERABILITY DATA UP TO 12 MONTHS3

In a 40-week, long-term, follow-up study of SEYSARA use, the rate of serious adverse events, severe treatment-emergent adverse events (TEAEs), and treatment-related TEAEs were similar to those observed in the 12-week pivotal studies.2,3

There are no reported associations with serious GI conditions to date, including IBD.1-3
STUDY 1a
 
Safety
population, n (%)
 
SEYSARA
(n = 481)
TEAEs (≥2% in either group)
Nasopharyngitis
15 (3.1)
Upper respiratory tract infection
8 (1.7)
Headache
13 (2.7)
Nausea
22 (4.6)
Vomiting
10 (2.1)
Urinary tract infection
1 (0.2)
STUDY 2b
 
SEYSARA
(n = 513)
 
 
13 (2.5)
8 (1.6)
15 (2.9)
10 (1.9)
1 (0.2)
2 (0.4)
STUDY 3c
 
Safety
population, n (%)
Placebo/
SEYSARAd
n = 236
SEYSARA/
SEYSARAd
n = 247
Total
N = 483
TEAEs (≥2% in either group)
Nasopharyngitis
13 (5.5)
5 (2.0)
18 (3.7)
Upper respiratory tract infection
7 (3.0)
9 (3.6)
16 (3.3)
Headache
9 (3.8)
5 (2.0)
14 (2.9)
Nausea
4 (1.7)
6 (2.4)
10 (2.1)
Vomiting
3 (1.3)
6 (2.4)
9 (1.9)
Urinary tract infection
2 (0.8)
5 (2.0)
7 (1.4)

a Study 1 = SC1401.
b Study 2 = SC1402.
c Study 3 = SC1403.
d Placebo/SEYSARA patients received placebo in the pivotal studies and sarecycline in the long-term study. SEYSARA/SEYSARA patients received sarecycline in the double-blind, pivotal studies and in the long-term safety study.

DOSING

CONVENIENT WEIGHT-BASED DOSING1

  • Once-daily dosing that can be taken anytime, with or without food1
  • Three available doses based on patient weight1
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HOW IT WORKS

During the transition of whiteheads and blackheads to papules and pustules, active white blood cells produce increasing amounts of inflammatory cytokines and mediators (such as IL-8, IL-12, and beta-defensins) in an attempt to combat the bacterial infection.7

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Tetracycline antibiotics inhibit protein synthesis and bacterial growth in addition to having anti-inflammatory properties. This makes them a suitable treatment for acne, with its inflammatory papules and pustules.8,9

The mechanism of action of SEYSARA in treating acne vulgaris is not known.

RESOURCES AND PATIENT SAVINGS

Eligible patients with private health (non-government) insurance only. Terms and conditions may apply

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PATIENT LEAFLET
Access the SEYSARA patient leaflet, a guide for your patients starting treatment

DOWNLOAD PDF
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SKINCARE PRODUCTS
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References:

  1. SEYSARA Package Insert. Almirall, LLC.
  2. Moore A, Green LJ, Bruce S, et al. Once-daily oral sarecycline 1.5 mg/kg/day is effective for moderate to severe acne vulgaris: results from two identically designed, phase 3, randomized, double-blind clinical trials. J Drugs Dermatol. 2018;17(9):987-996.
  3. Pariser DM, Green LJ, Lain EL, et al. Safety and tolerability of sarecycline for the treatment of acne vulgaris: results from a Phase III, multicenter, open-label study and a Phase I phototoxicity study. J Clin Aesthet Dermatol. 2019;12(11):E53-E62.
  4. Acne clinical guideline. American Academy of Dermatology. Accessed June 12, 2020. https://www.aad.org/member/clinical-quality/guidelines/acne.
  5. Demirjian A, Sanchez GV, Finkelstein JA, et al. CDC Grand Rounds: getting smart about antibiotics. MMWR Morb Mortal Wkly Rep. 2015;64(32):871-873.
  6. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019.
  7. Tanghetti EA. The role of inflammation in the pathology of acne. J Clin Aesthet Dermatol. 2013;6(9):27-35.
  8. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e33.
  9. Griffin MO, Ceballos G, Villarreal FJ. Tetracycline compounds with non-antimicrobial organ protective properties: possible mechanisms of action. Pharmacol Res. 2011;63(2):102-107.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

SEYSARA (sarecycline) tablet 60/100/150 mg, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

Limitations of Use: Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

WARNINGS AND PRECAUTIONS

  • Like other tetracyclines, SEYSARA can cause fetal harm when administered to a pregnant woman. If SEYSARA is used during pregnancy, or if the patient becomes pregnant while taking SEYSARA, the patient should be informed of the potential hazard to the fetus and treatment should be stopped immediately.
  • The use of SEYSARA during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
  • Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA.
  • Central nervous system side effects, including light-headedness, dizziness or vertigo, have been reported with tetracycline use. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued.
  • Intracranial hypertension in adults and adolescents has been associated with the use of tetracyclines. Clinical manifestations include headache, blurred vision and papilledema. Although signs and symptoms of intracranial hypertension resolve after discontinuation of treatment, the possibility for sequelae such as visual loss that may be permanent or severe exists. Concomitant use of isotretinoin and SEYSARA should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension.
  • Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using SEYSARA.
  • Bacterial resistance to tetracyclines may develop in patients using SEYSARA. Because of the potential for drug-resistant bacteria to develop during the use of SEYSARA, it should only be used as indicated.
  • As with other antibiotic preparations, use of SEYSARA may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, SEYSARA should be discontinued and appropriate therapy instituted.

ADVERSE REACTIONS

The most common adverse reaction (incidence ≥1%) was nausea: SEYSARA 3.1% vs placebo 2.0%.1

Please see full Prescribing Information.

To report an adverse event or product complaint, call or email:
Medical Affairs and Customer Relations
Phone: 1-866-665-2782
Fax: 510-595-8183
Email: almirallmc@eversana.com

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Almirall’s primary concern is to safeguard the well-being of our employees, their families, the dermatology community and patients. As such we are continuously monitoring developments regarding the Coronavirus pandemic (COVID-19) and implementing all applicable local, state and national guidance’s. We remain committed to maintaining access to information on our products and services, so if you cannot connect with your Almirall sales professional please call 1-866-665-2782. Our product copay cards can be found at our Almirall Advantage website, www.almiralladvantage.com, and patient samples can be requested at www.almirallsamples.com.

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