Primary Efficacy Results

  • Absolute change in comedonal lesion counts with ONEXTON Gel was -19.2 vs -9.6 for vehicle (P<0.001)1,2
  • Absolute change in inflammatory lesion counts with ONEXTON Gel was -16.3 vs -8.2 for vehicle (P<0.001)1,2
  • 35% of patients experienced treatment success† (n=253) vs 17% with vehicle (n=245) (P<0.001)1,2

†Treatment success=at least a 2-grade improvement in EGSS at Week 12.2

EGSS=Evaluator’s Global Severity Score.1,2

EGSS scale: 0 (clear); 1 (almost clear); 2 (mild); 3 (moderate); 4 (severe); 5 (very severe).1,2

SIGNIFICANT COMEDONAL MEAN LESION REDUCTIONS IN A CLINICAL TRIAL1-3

Post hoc results

Teen females‡

0.0%
(n=60)

vs vehicle 24.9%
(n=55)
P<0.001

Teen males‡

0.0%
(n=95)

vs vehicle 15.9%
(n=79)
P<0.001

Adult females§

0.0%
(n=29)

vs vehicle 34.0%
(n=43)
P=0.020

Severe patients

0.0%
(n=41)

vs vehicle 21.1%
(n=45)
P=0.001

  • Onexton
  • Vehicle

Post hoc analysis of the results of a Phase 3, multicenter, randomized, double-blind, vehicle-controlled group study comparing the efficacy and safety of ONEXTON Gel once daily for 12 weeks with vehicle gel in patients 12 years and older with moderate to severe acne vulgaris (baseline 20-100 comedonal lesions).1,2

‡ ≥12 and <18

§ ≥25

SIGNIFICANT INFLAMMATORY MEAN LESION REDUCTIONS IN A CLINICAL TRIAL1-3

Post hoc results

Teen females‡

0.0% (n=60)

vs vehicle 18.2%
(n=55)
P<0.001

Teen males‡

0.0% (n=95)

vs vehicle 23.7%
(n=79)
P<0.001

Adult females§

0.0% (n=29)

vs vehicle 39.7%
(n=43)
P=0.019

Severe patients

0.0% (n=41)

vs vehicle 19.2%
(n=45)
P<0.001

  • Onexton
  • Vehicle

Post hoc analysis of the results of a Phase 3, multicenter, randomized, double-blind, vehicle-controlled group study comparing the efficacy and safety of ONEXTON Gel once daily for 12 weeks with vehicle gel in patients 12 years and older with moderate to severe acne vulgaris (baseline 20-40 inflammatory lesions).1,2

‡ ≥12 and <18

§ ≥25


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Indication

ONEXTON® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

Important Safety Information

Contraindications

  • ONEXTON Gel is contraindicated:

    - in patients with a known hypersensitivity to clindamycin, benzoyl peroxide, any component of the formulation, or lincomycin. Anaphylaxis, as well as other allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

    - ­in patients with a history of regional enteritis, ulcerative colitis, or antibiotic‐associated colitis.

Warnings and Precautions

  • Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. ONEXTON Gel should be discontinued if significant diarrhea occurs.
  • Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death.
  • ONEXTON Gel should not be used in combination with erythromycin‐containing products because of its clindamycin component. Concomitant topical acne therapy should be used with caution due to possible cumulative irritation.
  • There are no available data on use in pregnant women. The developmental benefits of breastfeeding should be considered along with the mother's clinical need for ONEXTON. If used during nursing, avoid ingestion by the infant.
  • Patients should be advised to avoid contact with the eyes or mucous membranes.
  • Patients should minimize sun exposure (including tanning beds and sunlamps) following drug application.

Adverse Reactions

  • The most common local adverse reactions experienced by patients in clinical trials were mild and moderate erythema, scaling, itching, burning and stinging.

To report SUSPECTED ADVERSE REACTIONS call Bausch Health at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please click here for full Prescribing Information.

*This offer is only valid for patients with commercial insurance. Eligible uninsured patients will pay more. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid in Massachusetts or Minnesota or where otherwise prohibited, taxed or otherwise restricted. Click here for other terms and conditions that apply.

References: 1. Data on file. 2. ONEXTON [prescribing information]. Bridgewater, NJ. Bausch Health US, LLC.  3. Pariser DM, Rich P, Cook-Bolden FE, Korotzer A. An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris. J Drugs Dermatol. 2014;13(9):1083-1089.

References: 1. ONEXTON [prescribing information]. Bridgewater, NJ. Bausch Health US, LLC.  2. Pariser DM, Rich P, Cook-Bolden FE, Korotzer A. An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris. J Drugs Dermatol. 2014;13(9):1083-1089. 3. Data on file.

References: 1. Pariser DM, Rich P, Cook-Bolden FE, Korotzer A. An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris. J Drugs Dermatol. 2014;13(9):1083-1089. 2. ONEXTON [prescribing information]. Bridgewater, NJ. Bausch Health US, LLC.  3. Data on file.

References: 1. ONEXTON [prescribing information]. Bridgewater, NJ. Bausch Health US, LLC.  2. Nguyen TA, Eichenfield LF. Profile of clindamycin phosphate 1.2%/benzoyl peroxide 3.75% aqueous gel for the treatment of acne vulgaris. Clin Cosmet Investig Dermatol. 2015;8:549-554. 3. Bucks DAW, Pillai RS, McCall-Perez F. Advances in formulation technologies: creating highly effective and well-tolerated topical dermatologicals. Skin Aging. 2010(July suppl):S4-S6. 4. Data on file.  5. Bhatia N, Pillai R. Randomized, observer-blind, split-face compatibility study with clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel and facial foundation makeup. J Clin Aesthet Dermatol. 2015;8(9):25-32.