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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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CLINICAL STUDIES

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.1-3

SEYSARA was administered orally once-daily for 12 weeks as 60 mg, 100 mg, or 150 mg tablets, based on patient weight.2

Co-Primary Endpoints (Week 12)

  • Mean absolute reduction from baseline in inflammatory lesion counts1-3
  • IGA success rate1-3

Secondary Endpoints (Weeks 3, 6, and 9)

  • Mean absolute and percent reduction from baseline in inflammatory lesion counts2,3
  • Post Hoc Analyses
    • Non-facial IGA (chest and back)2,3
  • Safety Analyses
    Treatment-emergent adverse events (TEAEs) and vital signs were measured at every visit. Clinical laboratory evaluations, electrocardiograms (ECGs) and physical examinations were conducted at least at screening and week 12 for every patient.2
IGA, Investigator’s Global Assessment. Study 1 = SC1401; Study 2 = SC1402. 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). IGA scale for inflammatory lesions of acne reflects the investigator’s overall general assessment of the quantity and quality of inflammatory lesions (range 0-4 with 0 being clear and 4 being severe).2 This is not an exhaustive list of the secondary endpoints for Study 1 and Study 2.

PATIENT POPULATION1-3

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KEY INCLUSION CRITERIA2,3

Subjects were included in the study if they met the following criteria:

Weight:
33 to 136 kg (73 to 300 lbs)
Facial acne vulgaris with:
  • Lesions: 20 to 50 inflammatory; ≤ 100 non-inflammatory
  • Nodules: ≤ 2
  • IGA score: 3 (moderate) or 4 (severe)
  • KEY EXCLUSION CRITERIA2,3

    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.

STUDY RESULTS

VISIBLE ACNE CLEARANCE ACROSS TWO PHASE 3 TRIALS1,2

Compared to placebo, SEYSARA demonstrated:

Greater mean absolute reduction from baseline in inflammatory lesion counts at Week 121,2

An increased rate of IGA success at Week 121,2
IGA, Investigator’s Global Assessment.
ITT, intent-to-treat Study 1 = SC1401; Study 2 = SC1402. 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). IGA scale for inflammatory lesions of acne reflects the investigator’s overall general assessment of the quantity and quality of inflammatory lesions (range 0-4 with 0 being clear and 4 being severe).2

EARLY ONSET FOR VISIBLE RESULTS1

Compared to placebo, SEYSARA demonstrated:

Significant inflammatory lesion count reduction in as little as 3 weeks1
~50% mean reduction of inflammatory lesions at Week 121
Study 1 = SC1401; Study 2 = SC1402. Week 3 results were secondary outcome measures.

NOT JUST FOR THE FACE2,3

In addition to facial acne, chest and back acne were evaluated as secondary endpoints in the SEYSARA pivotal trials.2,3

Patients who had an IGA score of 2 or above for chest or back were included in the assessment.2,3,*

SEYSARA showed statistically significant improvement in both IGA for chest and back acne at Week 12.2,3


CHEST ACNE:IGA SUCCESS

BACK ACNE: IGA SUCCESS
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). Study 1 = SC1401; Study 2 = SC1402. IGA success data for chest and back were analyzed post hoc.

TOLERABILITY

DEMONSTRATED SAFETY PROFILE

Who participated in the study?

Studied in 2,133 patients with moderate to severe acne across three controlled clinical trials.1-3

What is SEYSARA’s safety profile?

Demonstrated safety profile with low rates of GI adverse events, vestibular effects, and phototoxicity.2
  • The only adverse drug reaction that was reported in at least 1% of subjects was nausea, SEYSARA (3.1%) vs placebo (2.0%).1

Can SEYSARA be taken by preteens?

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

PHASE 3 CLINICAL STUDIES1-3

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

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

OPEN-LABEL LONG-TERM SAFETY STUDY

In a 40-week long-term follow-up study of SEYSARA use, the rate of serious adverse events, severe treatment-emergent adverse effects (TEAEs), and treatment-related TEAEs were similar to those observed in the 12-week pivotal studies.4

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

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.5

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Tetracycline-derived antibiotics are protein synthesis inhibitors that are known to inhibit bacterial growth in addition to having anti-inflammatory properties. This is what makes them a suitable treatment for acne, considering the role inflammation plays in this disease.6

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

RESOURCES AND PATIENT SAVINGS

EASY, AFFORDABLE ACCESS

Patient savings may be available through Almirall Advantage*

Eligible patients with commercial insurance (non-government) may pay as little as $0 or no more than $50 on SEYSARA with the Almirall Advantage co-pay card.

Click below to download the card.

GET THE CARD

If your patients prefer to receive the co-pay card on a mobile device, instruct them to text “SEYSARA” to 39107. Message and data rates may apply.

PATIENT LEAFLET
To access the SEYSARA patient leaflet, a guide to helping your patients with starting their treatment, please click below:

DOWNLOAD PDF

OTHER ALMIRALL SKINCARE PRODUCTS
To see the rest of our dermatological products, please click below:

VIEW PRODUCTS

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

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

SEYSARA (sarecycline) tablet, 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

Most common adverse reaction (incidence ≥ 1%) is nausea.

Please see accompanying 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@dlss.com

REFERENCES:

  1. SEYSARA [package insert]. Exton, PA: Almirall, LLC, 2018.
  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. Data on file, Almirall, LLC. CSR SC1401 30JUN2017 and CSR 1402. 2017.
  4. Data on file, Almirall, LLC. CSR SC1403 03AUG2017. 2016.
  5. Tanghetti EA. The role of inflammation in the pathology of acne. J Clin Aesthet Dermatol. 2013;6(9):27-35.
  6. Griffin MO, Ceballos G, Villarreal FJ. Tetracycline compounds with non-antimicrobial organ protective properties: possible mechanisms of action. Pharmacol Res. 2011;63(2):102-7.