SERNIVO AT WORK

POWERFUL EFFICACY

In 2 clinical studies with SERNIVO Spray in adults with moderate psoriasis (n=538):

Significant treatment success versus vehicle in moderate psoriasis1,a

  • Day 15 (20.3% vs 5%, respectively; P<.001)
  • Day 29 (38.7% vs 12.6%, respectively; P<.001)

Pooled treatment success analysis as defined by IGA=0 or 1 and ≥2-grade reduction from baseline1

*Primary endpoint; **Secondary endpoint P value calculated using Cochran-Mantel-Haenszel test IGA = Investigator’s Global Assessment

FAST RESULTS

Study population included adult plaque psoriasis patients with 10% to 20% BSA1

Patients who achieved a ≥50% reduction in Total Sign Score (TSS50)1,a,b

TSS was graded for a target lesion selected at baseline on a 0-3 point scale.1

Patient-reported itching decreased by approximately 50%1,c

Investigator’s Global Assessment of treatment success1,a

Treatment success was defined as an Investigator’s Global Assessment (IGA) of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.1

34.3% of patients achieved a ≥50% reduction in (TSS50)at Day 4 (vs 22% for vehicle; P=.004)1,a

Investigator’s Global Assessment of treatment success1,a

Treatment success was defined as an Investigator’s Global Assessment (IGA) of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.1

In a Single Phase III Trial: IGA results for SERNIVO Spray and diprolene lotion were numerically similar. Study was not powered to compare efficacy of SERNIVO and diprolene2

Of the 628 subjects enrolled, 37.9% had target lesion located on their elbow or knee selected for assessment (SERNIVO, n=133;diprolene lotion, n=32; vehicle, n=71).

Investigator’s Global Assessment of treatment success1,a

Treatment success was defined as an Investigator’s Global Assessment (IGA) of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.1


Want to see more of SERNIVO at work?
Progress photographed at Days 1, 4, 15, and 29 are a click away.d

BSA=Body Surface Area
*Primary endpoint; **Secondary endpoint
aPooled data based on results from 2 randomized, controlled studies of adults with moderate plaque psoriasis with similar methodology. Subjects were randomized to either SERNIVO (n=356), diprolene lotion (n=90), or vehicle (n=182). Treatment success was defined as an Investigator’s Global Assessment (IGA) of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline. 1,3bTotal Sign Score was graded for a target lesion selected at baseline on a 0-3 point scale with greater than or equal to a 50% reduction in symptoms.cItching was assessed proactively and analyzed using Fisher’s exact test, with subjects asked if they were experiencing itching (yes/no) at each visit (Days 4, 8, 15, and 29) or had experienced itching since their last visit. Post-hoc analysis. 4dResults may vary.

FOCUSED DELIVERY

SERNIVO is formulated for balance, providing high penetration and permeation in the epidermis and dermis, with low systemic absorption5,e

Delivery that utilizes long-chain oleyl alcohol6,7 and is formulated to deliver the active ingredient to the skin layers affected most by plaque psoriasis.5,7

eOf several prototype formulations tested in vitro, SERNIVO provided the best balance of high penetration/permeation and low absorption.5

PROVEN TOLERABILITY

During 28 days of treatment with SERNIVO, few patients experienced adverse events7

Adverse reactions occurring in ≥1% of patients treated with SERNIVO for up to 4 weeks7

SERNIVO is approved for up to 4 weeks of use7

VERSATILE AND ELEGANT

In skin hydration and elasticity studies, SERNIVO demonstrated emollient-like properties and significantly improved skin elasticity at 1 hour (P<.01)8

Easy Application

Spray mechanism allows for easy application on hard-to-reach areas, even upside-down

Effective

Effective for plaques on the back, in addition to hard-to-treat elbows and knees,1 and hairy areasf,g

Nongreasy

SERNIVO formulation is nongreasy9 and may provide a patient-friendly treatment experience

Not actual patients.

 

fIn clinical studies, more than one-third of all target lesions were on elbows or knees.6
gAvoid use on the face, scalp, axilla, groin, or other intertriginous areas.

IMPORTANT SAFETY INFORMATION

SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia or unmasking of latent diabetes mellitus, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Do not use if atrophy is present at the treatment site. Do not use with occlusive dressings. Avoid use on the face, scalp, axilla, groin or other intertriginous areas. Use of SERNIVO Spray is not recommended in pediatric patients as they are more susceptible to systemic toxicity. Allergic contact dermatitis may occur. The most common adverse reactions (≥1%) were application site pruritus, burning and/or stinging, pain, and atrophy. Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. These are not all the possible side effects of SERNIVO Spray.
Please refer to Full Prescribing Information.

INDICATION AND USAGE

SERNIVO Spray is indicated for the treatment of mild-to-moderate plaque psoriasis in patients 18 years of age or older.

To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1-888-966-8766 or contact the FDA at
1-800-FDA-1088.

References: 1. Gold LS, Jackson JM, Knuckles MLF, Weiss JS. Improvement in extensive moderate plaque psoriasis with a novel emollient spray formulation of betamethasone dipropionate 0.05%. J Drugs Dermatol. 2016;15(3):334-342. 2. Kircik L, Bagel J. DFD-01, a novel emollient spray formulation of 0.05% betamethasone dipropionate, effectively treats plaque psoriasis on knees and elbows. Poster presented at: Winter Clinical Dermatology Conference; January 15-20, 2016; Koloa, HI. 3. Gold LS, Pariser D, Jackson JM. DFD-01, a midpotent betamethasone dipropionate 0.05% in an emollient-like spray formulation demonstrates similar efficacy to a super potent topical steroid for the treatment of moderate plaque psoriasis. Poster presented at: Annual Fall Dermatology Conference; November 3-6, 2016; Las Vegas, NV. 4. Zirwas M, Hebert A. Fast relief of itching in psoriasis with DFD-01, a novel medium-potency emollient spray formulation of betamethasone dipropionate 0.05%. Poster presented at: Winter Clinical Dermatology Conference; January 13-18, 2017; Kona, HI. 5. Kircik L, Okumu F, Kandavilli S, Sugarman J. Rational vehicle design ensures targeted cutaneous steroid delivery. J Clin Aesthet Dermatol. 2017;10(2):12-19. 6. Fowler J, Hebert A, Sugarman J. DFD-01, a novel medium potency betamethasone dipropionate 0.05% emollient spray, demonstrates similar efficacy to augmented betamethasone dipropionate 0.05% lotion for the treatment of moderate plaque psoriasis. J Drugs Dermatol. 2016;15(2):154-162. 7. SERNIVO Prescribing Information. Promius Pharma, LLC. Princeton, NJ. February 2016. 8. Jackson JM, Grove GL, Allenby K, Houser T. DFD-01 reduces transepidermal water loss and improves skin hydration and flexibility. Dermatol Ther. 2017;7(4):507-514. 9. US Food and Drug Administration NDA # 208079. Dr. Reddy’s Laboratories, Princeton, NJ: Feb 2016.

Eligibility Rules

Patient Instructions: Redeem this coupon ONLY when accompanied by a valid presciption for SERNIVO® (betamethasone dipropionate) Spray, 0.05%. Commercially insured patients pay $0 for their prescription. Maximum reimbursement limits apply. This card must be presented at the time of fill for instant savings. Offer is good for commercially insured patients only. This coupon is good for up to 12 uses and is not transferable.
Please consult Full Prescribing Information for SERNIVO. Not valid for cash-paying patients or patients reimbursed by federal healthcare programs, including Medicare, Medicaid, Tri Care, the Department of Veterans Affairs, state maternal and child health block grant programs under 42 U.S.C. 701 et. seq. state social service block grant programs under 42 U.S.C. section 1397 et. seq. or any other similar federal or state healthcare program. Void where prohibited by law, taxed or restricted. Void outside the United States. Void for residents of Massachusetts. Patient is responsible for reporting receipt of card program rewards to any private insurer that pays for or reimburses any part of the prescriptions filled with this card. Void if reproduced. It is illegal for any person to sell, purchase, or trade, or offer to sell, purchase or trade, or to counterfeit this card. Offer expires 12 months after initial use. Promius Pharma reserves the right to rescind, revoke or amend this offer at any time without notice.  

Download Co-Pay Card

THANK YOU

Thank you for signing up to receive news and information about SERNIVO. To fill out a sample request form, click the button below.

Download Sample Form Download Co-Pay Card

IMPORTANT SAFETY INFORMATION
SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Systemic effects of topical corticosteroids may also manifest as Cushing's syndrome, hyperglycemia or unmasking of latent diabetes mellitus, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-poten cy topical corticosteroids..