IMPORTANT SAFETY INFORMATION

PRESCRIBING INFORMATION

Answer Study

 

Not an actual patient
 

Let's clear up the facts

Combination treatment has the potential to improve outcomes. For this study, we added ORACEA® (doxycycline, USP) 40mg* Capsules to SOOLANTRA® (ivermectin) Cream, 1% to measure efficacy and ensure the treatment approach aims for 'clear'.1 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 and cooperative effects on the inflammatory pathways of rosacea.

SOOLANTRA® (ivermectin) Cream tube and Oracea® (doxycycline, USP) Capsules bottle

Two weeks in and I have already started to see a noticable improvement with my rosacea bumps and blemishes†

Woman with rosacea.

Not an actual patient

†Individual results may vary

SOOLANTRA Cream: Pivotal Study Information

Study Design

The efficacy and safety of SOOLANTRA Cream, 1% QD* was evaluated in 1371 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

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

SOOLANTRA Cream Pivotal Studies: Subject Demographics**

Table showing the subject demographics in both Study 1 and Study 2.

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.

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

Graph showing IGA success rate at weeks 2, 4, 8, and 12 in studies 1 and 2. In Study 1 SOOLANTRA had a 38.4% IGA success rate compared to the vehicle cream at 11.6%. In Study 2 SOOLANTRA had a 40.1% IGA success rate compared to the vehicle cream at 18.8%.

IGA success was defined as achieving clear or almost clear

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

Graph showing mean change in inflammatory lesion count at weeks 2, 4, 8, and 12 in studies 1 and 2. In Study 1 SOOLANTRA had a -20.5 mean change in IL count compared to the vehicle cream at -12.0. In Study 2 SOOLANTRA had a -20.5 mean change in IL count compared to the vehicle cream at -13.4.

Inflammatory lesion count continued to improve throughout the study
The most common adverse reactions (incidence ≤ 1%) included skin burning sensation and skin irritation

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

Table showing the long-term safety (treatment related AEs) in both Study 1 and Study 2.

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.

With SOOLANTRA Cream, Clearer Is Possible!

  • Proposed Dual MOA of Ivermectin*
    • Anti-inflamatory and anti-parasitic activity of ivermectin has been shown5,6
  • Superior Efficacy to METROCREAM Topical Cream, 0.75%
    • A phase 3, investigator-blinded, mulicenter, 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 in clinical trials3,7
    • 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%
    • 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 vehicle
    • No severe or serious AEs were considered related to SOOLANTRA Cream or AzA

*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).

RETURN TO EFFICACY

Important Safety Information

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.

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.

References: 1. Webster G, et al. Defining treatment success in rosacea as ‘clear’ may provide multiple patient benefits:results of a pooled analysis. J Dermatology Treat. 2017; 4: 1–6. 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 Eur Acad Dermatol Venereol. 2017;31(11):1907–1911. 7. Taieb A, et al. Br J 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.

See Important Safety Information

IMPORTANT SAFETY INFORMATION

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

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.

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