EFFICACY

2 PHASE 3 TRIALS

Class 1 efficacy at week 8, when applied once daily, with continued results 4 weeks post treatment1,2

Treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of "clear" or "almost clear" at week 8 primary endpoint.2

The treatment difference at week 2 in trial 2 was not statistically significant.

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Study Design

The safety and efficacy of BRYHALI Lotion were assessed in 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).2

POOLED ANALYSIS

Significant clearance with less steroid exposure2

  • 37.5% of patients had treatment success at week 8 vs 10.0% for vehicle (P<0.001 from trials 1 and 2)
  • The only single-agent low-concentration halobetasol (0.01%) formulation

No increased epidermal atrophy observed through 8 weeks of once-daily treatment1,2

  • Pooled analysis of 2 phase 3 trials: In both the BRYHALI Lotion and vehicle groups, an average of 0.8% of patients had epidermal atrophy at week 8. All cases were already present at baseline.§
  • Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, hypopigmentation and allergic contact dermatitis. Some local adverse reactions may be irreversible.

§In a phase 2 trial, there was 1 case of epidermal atrophy at week 6, which was not reported at weeks 8 and 12.3

POOLED ANALYSIS: 2 PHASE 3 TRIALS

Significant symptomatic relief as early as 2 weeks2

Reported as "erythema" in both phase 3 clinical trials. **Statistical significance was seen for plaque elevation at week 4 (43.0% vs 18.5%). P<0.001 from trials 1 and 2.

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Study Design

The safety and efficacy of BRYHALI Lotion were assessed in 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).2

Deliver the relief they need and the safety you want with the only single-agent, high-potency corticosteroid indicated for treatment up to 8 weeks1,2,4

Plus reductions in local skin reactions2

PHASE 2 TRIAL vs ULTRAVATE CREAM

At week 2, BRYHALI Lotion delivered similar clearance with 80% less halobetasol1,2,4

††Treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of "clear" or "almost clear" at week 2 primary endpoint.2QD = once daily

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Study Design

150 patients with moderate-to-severe plaque psoriasis were studied in a multicenter, double-blind, randomized, parallel-group phase 2 clinical trial to assess the safety, tolerability, and efficacy of BRYHALI Lotion vs Ultravate Cream. Subjects were over the age of 18 with moderate-to-severe cases, defined as an IGA score of 3 or 4 and covering at least 3% but no more than 12% of BSA, excluding the face, scalp, palms, soles, groin, axillae, and intertriginous areas. Subjects were randomized in a 4:4:1:1 ratio to be treated with 1 of 4 topical treatments: BRYHALI Lotion (60 subjects); Ultravate Cream (57 subjects); vehicle lotion (17 subjects); or vehicle cream (16 subjects). Subjects applied the study drug once daily for 2 weeks and returned to the clinic for post-baseline evaluations at week 2.2

Only once-daily BRYHALI Lotion provides Class 1 clearance approved for use for up to 8 weeks

Efficient penetration with advanced delivery technology

SAFETY & TOLERABILITY

2 PHASE 3 TRIALS

Chart a course to symptomatic relief with established safety1,2

Pooled analysis of patients using BRYHALI Lotion in 2 phase 3 trials revealed:1,2

  • No serious treatment-related adverse events
  • Drug-related adverse events were reported by only 1.8% of patients
  • No increased epidermal atrophy observed through 8 weeks of treatment. In both the BRYHALI Lotion and vehicle groups, an average of 0.8% of patients had epidermal atrophy at week 8. All cases were already present at baseline.
  • Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, hypopigmentation and allergic contact dermatitis. Some local adverse reactions may be irreversible.
SEE THE STUDY DESIGN
 

Study Design

The safety and efficacy of BRYHALI Lotion were assessed in 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).2
Effect on the endocrine system (Hypothalamic-Pituitary-Adrenal Axis Suppression)

BRYHALI Lotion has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis during or upon withdrawal from treatment with a topical corticosteroid; therefore, patients may require periodic evaluation for evidence of HPA axis suppression. If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid.1

The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression with BRYHALI Lotion was evaluated in a study of 19 adult subjects with moderate to severe plaque psoriasis involving ≥20% of their body surface area (BSA). HPA axis suppression was reported for 1 (5.6%) subject at Week 4 and for 3 (15.8%) subjects at Week 8. All 3 subjects had a normal HPA axis suppression test with discontinuation of treatment.1

Local adverse reactions

Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, hypopigmentation and allergic contact dermatitis. Some local adverse reactions may be irreversible1

Ophthalmic adverse reactions

Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.1

Concomitant skin infections

Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of BRYHALI Lotion until the infection has been adequately treated.1

Allergic contact dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue BRYHALI Lotion if allergic contact dermatitis occurs.1

Most common adverse reactions
  • The most common adverse reactions (≥1% and more than vehicle) were upper respiratory tract infections, application site dermatitis, and hyperglycemia.
  • No serious treatment-related adverse events were reported.1
  • Only 1.8% of patients reported drug-related adverse events.1,2
No increased epidermal atrophy

In two 8-week phase 3 trials, 0.0% of BRYHALI Lotion patients in trial 1 and 1.5% in trial 2 experienced epidermal atrophy vs 0.0% and 1.5% for those using vehicle (respectively). In both groups, all cases of epidermal atrophy were already present at baseline.2

2 PIVOTAL PHASE 3 TRIALS

Tolerability assessment: Improvements in local skin reactions2

‡‡Reported as burning/stinging in both phase 3 clinical trials.

SEE THE STUDY DESIGN
 

Study Design

The safety and efficacy of BRYHALI Lotion were assessed in 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).2

Substantial reductions in local skin reactions from baseline to week 2 and continued through week 81,2

With significant symptomatic relief2

2 PHASE 3 TRIALS

Navigate the risk of epidermal atrophy with the lowest concentration halobetasol (0.01%)2

No increased epidermal atrophy observed through 8 weeks of once-daily treatment in pivotal trials
  • Pooled analysis of 2 phase 3 trials: In both the BRYHALI Lotion and vehicle groups, an average of 0.8% of patients had epidermal atrophy at week 8. All cases were already present at baseline.2§§
  • Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, hypopigmentation and allergic contact dermatitis. Some local adverse reactions may be irreversible.

§§In a phase 2 trial, there was 1 case of epidermal atrophy reported at week 6, which was not reported at weeks 8 and 12.3

SEE THE STUDY DESIGN
 

Study Design

The safety and efficacy of BRYHALI Lotion were assessed in 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).2

BEFORE AND AFTER

Set a course to Class 1 clearance1,2

Female aged 43 years treated once daily with BRYHALI Lotion
After (8 weeks)
Before (Baseline)

These photos represent actual clinical experience. Photos have not been retouched. Individual results may vary.

Set a course to Class 1 clearance1,2

Female aged 45 years treated once daily with BRYHALI Lotion
After (8 weeks)
Before (Baseline)

These photos represent actual clinical experience. Photos have not been retouched. Individual results may vary.

Set a course to Class 1 clearance1,2

Male aged 40 years treated once daily with BRYHALI Lotion
After (8 weeks)
Before (Baseline)

These photos represent actual clinical experience. Photos have not been retouched. Individual results may vary.

VEHICLE BENEFIT

Micron-sized emulsion droplets designed for optimal delivery

Transmission electron micrograph of BRYHALI Lotion. Magnified 10,000 times.

Strengthened barrier function and increased moisture retention2

Progressive decrease in trans-epidermal water loss (TEWL)2

  • 8 hours after vehicle application, the skin barrier was 50% more effective at retaining water than at time 0

Increased moisture retention up to 24 hours2

  • 15 minutes after vehicle application, there was 107% more water in the skin than at time 0
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Study Design

The trans-epidermal water loss (TEWL) and moisture content of skin sites treated with BRYHALI Lotion vs untreated sites were measured in 30 patients at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 8 hours, and 24 hours. Evaluations were made by a trained technician using the tewameter and corneometer.2

EX VIVO STUDY vs ULTRAVATE CREAM¶¶

More efficient delivery with once-daily advanced lotion technology2

With targeted penetration and 80% less steroid exposure, BRYHALI Lotion delivered halobetasol to the epidermis more effectively than Ultravate cream1,2,4

  • As measured by a percentage of the applied dose, BRYHALI Lotion penetrated 3x more efficiently than Ultravate cream.
  • Absorption is defined as the halobetasol in the epidermis normalized to the halobetasol in the test product.

¶¶The clinical significance of these ex vivo data has not been established.

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Study Design

The dermal and epidermal levels of halobetasol as a percentage of applied medication were assessed in 20 skin grafts from a single, cadaveric source, measured at 0-6, 6-12, 12-18, and 18-24 hours.2

Chart a course to convenience with once-daily dosing in 2 sizes1

60g
100g

100% of patients in a satisfaction survey somewhat or strongly agreed that BRYHALI Lotion:2

ABSORBED QUICKLY
DID NOT LEAVE SKIN FEELING GREASY
HAD A LIGHTWEIGHT FEEL AFTER APPLICATION
LEFT SKIN FEELING MOISTURIZED FOR 24 HOURS
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Study Design

A total of 30 subjects (between the ages of 35 and 65) were equally divided into 2 groups of 15 to assess the customer perception and satisfaction of the BRYHALI Lotion vehicle vs another vehicle. Each subject applied the assigned lotion vehicle to one side of the face while leaving the other side untreated. Subjects then answered a survey to assess their satisfaction.2