Epsolay
Generic: BENZOYL PEROXIDE
Basic Information
Manufacturer
Mayne Pharma Commercial LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
641981e6-460b-44dd-8146-306c47e5367c
Indications & Usage
1 INDICATIONS AND USAGE EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.
EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.
( 1 )
EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 1%) are application site reactions: pain, erythema, pruritis and edema.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two randomized, double-blind, vehicle-controlled trials, adult subjects with rosacea applied EPSOLAY (N = 488) or vehicle (N = 234) once daily for 12 weeks.
The majority of subjects were Caucasian (93%) and female (73%) with a mean age of 51 years.
Table 1 presents the most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle.
Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with EPSOLAY and with Greater Frequency than Subjects Treated with Vehicle EPSOLAY N=488 Vehicle N=234 Application site pain 11 (2%) 2 (1%) Application site erythema 11 (2%) 2 (1%) Application site pruritus 6 (1%) 1 (<1%) Application site edema Application site edema includes: application site swelling and application site edema 4 (1%) 0 (0%) During the clinical trials, local tolerability evaluations were conducted at baseline and at each study visit by assessment of dryness, itching, scaling and stinging/burning.
Table 2 presents the local tolerability assessments by severity grade at Week 12.
Table 2: Facial Cutaneous Tolerability Assessment Sign/Symptom EPSOLAY N=455 Of the 488 subjects treated with EPSOLAY, 455 subjects had local tolerability assessments at Week 12.
Severity at Week 12 Mild Moderate Severe Dryness 25% 7% 0% Itching 24% 6% 0% Scaling 13% 4% 0% Stinging/Burning 20% 3% 1% In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment) the frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two randomized, double-blind, vehicle-controlled trials, adult subjects with rosacea applied EPSOLAY (N = 488) or vehicle (N = 234) once daily for 12 weeks.
The majority of subjects were Caucasian (93%) and female (73%) with a mean age of 51 years.
Table 1 presents the most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle.
Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with EPSOLAY and with Greater Frequency than Subjects Treated with Vehicle EPSOLAY N=488 Vehicle N=234 Application site pain 11 (2%) 2 (1%) Application site erythema 11 (2%) 2 (1%) Application site pruritus 6 (1%) 1 (<1%) Application site edema Application site edema includes: application site swelling and application site edema 4 (1%) 0 (0%) During the clinical trials, local tolerability evaluations were conducted at baseline and at each study visit by assessment of dryness, itching, scaling and stinging/burning.
Table 2 presents the local tolerability assessments by severity grade at Week 12.
Table 2: Facial Cutaneous Tolerability Assessment Sign/Symptom EPSOLAY N=455 Of the 488 subjects treated with EPSOLAY, 455 subjects had local tolerability assessments at Week 12.
Severity at Week 12 Mild Moderate Severe Dryness 25% 7% 0% Itching 24% 6% 0% Scaling 13% 4% 0% Stinging/Burning 20% 3% 1% In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment) the frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.