Berdazimerside effects

The most commonly reported adverse reactions (≥1%) are application site reactions, including pain (such as burning or stinging sensations, 18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%). To report SUSPECTED ADVERSE REACTIONS, contact LNHC, Inc. at 1-855-330-7546 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 three double-blind, vehicle-controlled clinical trials (Trial 1, and Trial 2 and Trial 3, which were similarly designed to Trial 1), 1596 adult and pediatric subjects were treated with ZELSUVMI or vehicle gel topically once daily for up to 12 weeks. In these trials 3% of subjects were less than 2 years of age, and 96% of subjects were 2 to 17 years of age. The trial population included 51% male, 88% White, 6% Black, and 6% Other; for ethnicity, 21% of subjects identified as Hispanic/Latino, 78% as non-Hispanic/Latino, and 1% were not reported. Adverse reactions reported by ≥1% of subjects and more frequently than vehicle-treated subjects are listed in Table 1.

Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with MC Treated with ZELSUVMI (and Greater than Vehicle) Day 1 through Week 12 in Trials 1, 2, and 3 ZELSUVMI N=916 Vehicle Gel N=680 Adverse Reaction Mild n (%) Moderate n (%) Severe n (%) Mild n (%) Moderate n (%) Severe n (%) Subjects with any TEAE* 220 192 16 118 47 4 Application Site Pain† 113 56 2 30 3 0 Application Site Erythema 48 55 4 7 2 0 Application Site Pruritus 36 15 1 5 2 0 Application Site Exfoliation 18 26 2 0 0 0 Application Site Dermatitis 16 26 3 3 2 0 Application Site Swelling 17 14 1 3 1 0 Pyrexia 14 6 0 6 1 0 Application Site Erosion 7 5 3 1 0 0 Application Site Discoloration 13 1 0 1 0 0 Application Site Vesicles 5 9 0 0 1 0 Vomiting 5 7 0 1 0 0 Application Site Irritation 7 4 0 0 0 0 Upper Respiratory Tract Infection 6 5 0 4 1 0 Application Site Infection 4 4 2 2 1 0 * TEAE – treatment emergent adverse events † Application site pain also includes application site burning and stinging.